Proximate PPH01Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10705036012993), received between Dec 7, 2017 and Jun 6, 2023 — classified as 80 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PERIRECTAL HEMATOMA AFTER STAPLED SURGERY FOR HEMORRHOIDAL PROLAPSE AND OBSTRUCTED DEFECATION SYNDROME: CASE SERIES MANAGEMENT TO AVOID PANIC-GUIDED TREATMENT. AUTHORS: DOMENICO MASCAGNI, CHIARA EBERSPACHER, GABRIELE NALDINI, FRANCESCO LEONE ARCIERI, PIETRO MASCAGNI, ROBERTO CIROCCHI, GEORGI POPIVANOV, PIERPAOLO SILERI, STEFANO ARCIERI. CITATION: UPDATES IN SURGERY (2023) 75:627¿634 HTTPS://DOI.ORG/10.1007/S13304-023-01490-Y. THE AIM OF THIS STUDY IS TO ANALYZE A HOMOGENOUS CASE SERIES OF PH AND TO DEFINE A TREATMENT ALGORITHM FOR HUGE POSTOPERATIVE PHS. A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE DATABASE OF THREE HIGH-VOLUME PROCTOLOGY UNITS WAS PERFORMED BETWEEN 2008 AND 2018, AND ALL PH CASES WERE ANALYZED. IN ALL, 3058 PATIENTS UNDERWENT STAPLING PROCEDURES FOR HEMORRHOIDAL DISEASE OR OBSTRUCTED DEFECATION SYNDROME WITH INTERNAL PROLAPSE. AMONG THESE, 14 LARGE PH CASES WERE REPORTED. ALL 14 PATIENTS WERE FEMALE, AGED 41¿70 YEARS. DIFFERENT TYPES OF STAPLERS AND SURGICAL TECHNIQUES WERE USED: TWO PATIENTS UNDERWENT HEMORRHOIDOPEXY (ONE WITH PPH01, ONE WITH PPH03), FIVE UNDERWENT STARR WITH TWO STAPLERS (TWO PPH01 IN THREE CASES AND TWO

  Patient problems: Failure to Anastomose; Hematoma; Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 17072890 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PERIRECTAL HEMATOMA AFTER STAPLED SURGERY FOR HEMORRHOIDAL PROLAPSE AND OBSTRUCTED DEFECATION SYNDROME: CASE SERIES MANAGEMENT TO AVOID PANIC-GUIDED TREATMENT. AUTHORS: DOMENICO MASCAGNI, CHIARA EBERSPACHER, GABRIELE NALDINI, FRANCESCO LEONE ARCIERI, PIETRO MASCAGNI, ROBERTO CIROCCHI, GEORGI POPIVANOV, PIERPAOLO SILERI, STEFANO ARCIERI CITATION: UPDATES IN SURGERY (2023) 75:627¿634 HTTPS://DOI.ORG/10.1007/S13304-023-01490-Y THE AIM OF THIS STUDY IS TO ANALYZE A HOMOGENOUS CASE SERIES OF PH AND TO DEFINE A TREATMENT ALGORITHM FOR HUGE POSTOPERATIVE PHS. A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE DATABASE OF THREE HIGH-VOLUME PROCTOLOGY UNITS WAS PERFORMED BETWEEN 2008 AND 2018, AND ALL PH CASES WERE ANALYZED. IN ALL, 3058 PATIENTS UNDERWENT STAPLING PROCEDURES FOR HEMORRHOIDAL DISEASE OR OBSTRUCTED DEFECATION SYNDROME WITH INTERNAL PROLAPSE. AMONG THESE, 14 LARGE PH CASES WERE REPORTED. ALL 14 PATIENTS WERE FEMALE, AGED 41¿70 YEARS. DIFFERENT TYPES OF STAPLERS AND SURGICAL TECHNIQUES WERE USED: TWO PATIENTS UNDERWENT HEMORRHOIDOPEXY (ONE WITH PPH01, ONE WITH PPH03), FIVE UNDERWENT STARR WITH TWO STAPLERS (TWO PPH01 IN THREE CASES AND TWO PP

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain

  MAUDE report 17072758 ↗
• MalfunctionJul 15, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE INSTRUMENT DID NOT TRIGGER. THEY FINISHED THE PROCEDURE WITH A NEW INSTRUMENT. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE LONGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15031422 ↗
• MalfunctionJun 7, 2022Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY, WHEN TRIGGERING THE DEVICE (LEVER) VERY SLUGGISH, NO CLICK. RENEWED TRIGGERING. BLEEDING DUE TO INCOMPLETE STAPLE SUTURE ROW (SECOND RELEASE) WITH SUBSEQUENT MANUAL SUTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14625732 ↗
• MalfunctionJul 23, 2021Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY, DURING FIRING IT DID NOT FIRE PROPERLY AND TISSUE WAS COMPROMISED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216824 ↗
• MalfunctionJun 3, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE PPH STAPLER FIRED, AND IT CUT BUT DID NOT STAPLE. THERE WAS NO DELAY TO THE SURGERY AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930017 ↗
• InjuryDec 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: RECTAL PERFORATION, RETROPNEUMOPERITONEUM, AND PNEUMOMEDIASTINUM AFTER STAPLING PROCEDURE FOR PROLAPSED HEMORRHOIDS: REPORT OF A CASE AND SUBSEQUENT CONSIDERATIONS. AUTHOR/S: VALTER RIPETTI, M.D., MARCO CARICATO, M.D., AUGUSTO ARULLANI, M.D. AUTHORS: VALTER RIPETTI, M.D; MARCO CARICATO, M.D; AUGUSTO ARULLANI, M.D. CITATION: A COMPLICATION OF STAPLED HEMORRHOIDECTOMY, VOL. 45, NO. 2; PP268-270. THIS IS A CASE STUDY THAT DISCUSSED ABOUT RECTAL PERFORATION, RETROPNEUMOPERITONEUM, AND PNEUMOMEDIASTINUM AFTER STAPLING PROCEDURE FOR PROLAPSED HEMORRHOIDS. A (B)(6) FEMALE PATIENT PRESENTED WITH A HISTORY OF OUTLET OBSTRUCTION AND PELVIC FLOOR DESCENT. FOR SIX MONTHS SHE COMPLAINED OF RECTAL BLEEDING NOT RELATED TO EVACUATION. PREOPERATIVE COLPOCYSTODEFECOGRAPHY SHOWED PELVIC FLOOR DESCENT, RECTORECTAL INTUSSUSCEPTION, AND ANTERIOR RECTOCELE. PROCTOSCOPY SHOWED SECOND-DEGREE AND THIRD-DEGREE HEMORRHOIDS AND MUCOSAL PROLAPSE. ANORECTAL MANOMETRY WAS NORMAL. PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) DEVICE (ETHICON) WAS USED DURING THE STAPLING PROCEDURE. DIGITAL RECTAL EXAMINATION SHOWED A POSTERIOR RECTAL PERFORATION ON THE STAPLE LINE. THE RECTU

  Patient problems: Inflammation; No Code Available

  MAUDE report 9535009 ↗
• InjuryDec 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: DAY-CASE STAPLED (CIRCULAR) VS. DIATHERMY HEMORRHOIDECTOMY, A RANDOMIZED, CONTROLLED TRIAL EVALUATING SURGICAL AND FUNCTIONAL OUTCOME. AUTHOR/S: MATTI KAIRALUOMA, M.D., PH.D., YOSTI NUORVA, M.D., PH.D., ILMO KELLOKUMPU, M.D., PH.D. CITATION: DIS COLON RECTUM 2003; 46:93¿99. THE AIMED OF THIS RANDOMIZED, CONTROLLED STUDY TO COMPARE THE EFFICACY AND VALUE OF STAPLED HEMORRHOIDECTOMY WITH THAT OF DIATHERMY HEMORRHOIDECTOMY IN A DAY-CASE. BETWEEN APRIL 1999 AND AUGUST 2000, 60 PATIENTS WERE ENROLLED IN THE STUDY IN WHICH 30 PATIENTS (MALE=19, FEMALE=11; MEAN AGE=48.5 YEARS, AGE RANGE=17-65 YEARS) UNDERWENT DIATHERMY HEMORRHOIDECTOMY AND 30 PATIENTS (MALE=13, FEMALE=17; MEAN AGE=47 YEARS, AGE RANGE=25-65 YEARS) STAPLED HEMORRHOIDECTOMY. THE PATIENTS UNDERWENT EITHER CONVENTIONAL HEMORRHOIDECTOMY WITH DIATHERMY DISSECTION AND WITHOUT PEDICLE LIGATION OR STAPLED HEMORRHOIDECTOMY BY MEANS OF THE PPH01 STAPLING DEVICE (ETHICON). REPORTED COMPLICATIONS INCLUDED MINOR SECONDARY BLEEDING FROM THE STAPLE LINE (N=2) ON DAYS 1 AND 7 AFTER SURGERY AND WAS TREATED BY ADRENALINE INJECTION; ANASTOMOTIC STENOSIS (N=1) AND WAS TREATED BY BALLOON DILATATION; TREA

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9534989 ↗
• MalfunctionSep 17, 2019Defective Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CUSTOMER INDICATED THAT THERE WAS A DEVICE MALFUNCTION. NO MORE INFORMATION IS AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077655 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: CLINICAL OUTCOMES OF STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFAECATION SYNDROME AT 10-YEAR FOLLOW-UP AUTHORS: M. SCHIANO DI VISCONTE, F. NICOLI, A. PASQUALI AND G. BELLIO CITATION: COLORECTAL DISEASE (2018); 2:614¿622. DOI:10.1111/CODI.14028. THE PRIMARY AIM OF THIS STUDY WAS TO EVALUATE THE CLINICAL OUTCOMES AND PATIENTS¿ SATISFACTION AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR OBSTRUCTED DEFAECATION SYNDROME (ODS) AT 10-YEAR FOLLOW-UP. THE SECONDARY AIM WAS TO DEFINE FACTORS THAT PREDICT THE RECURRENCE OF ODS AFTER STARR. THIS STUDY WAS A RETROSPECTIVE COHORT ANALYSIS CONDUCTED ON PROSPECTIVELY COLLECTED DATA. SEVENTY-FOUR CONSECUTIVE PATIENTS (8 MALE AND 66 FEMALE; MEAN AGE: 60.0 ±10.2; AGE RANGE: 29-77 YEARS) WHO UNDERWENT STARR FOR ODS BETWEEN JANUARY 2005 AND DECEMBER 2006 IN TWO ITALIAN HOSPITALS WERE INCLUDED. THREE SEMI-CIRCUMFERENTIAL PURSE-STRING SUTURES WERE PLACED IN THE ANTERIOR RECTAL WALL AND A 33-MM CIRCULAR STAPLER (PPH-01; ETHICON) WAS INSERTED, CLOSED AND FIRED. TWO SEMI-CIRCUMFERENTIAL PURSE STRING SUTURES WERE POSITIONED IN THE POSTERIOR RECTAL WALL AND A SECOND PPH-01 (ETHICON) STAPLER WAS USED. RE

  Patient problems: Blood Loss; No Code Available; Not Applicable; Pain

  MAUDE report 8862219 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: IMPACT OF STAPLED HAEMORRHOIDOPEXY ON STOOL CONTINENCE AND ANORECTAL FUNCTION¿LONG-TERM FOLLOW-UP OF 242 PATIENTS. AUTHORS: STEFAN RISS, PHILIPP RISS, MICHAEL SCHUSTER, THOMAS RISS. CITATION: LANGENBECKS ARCH SURG. 2008; 393: 501¿505. DOI: 10.1007/S00423-007-0257-3. SEVERAL STUDIES HAVE PROVED THE FEASIBILITY AND SAFETY OF STAPLED ANOPEXY FOR TREATING HEMORRHOIDAL PROLAPSE. HOWEVER, STOOL URGENCY AND FECAL INCONTINENCE AS POSSIBLE SIDE EFFECTS ARE STILL DEBATED. THE PRESENT STUDY WAS DESIGNED TO ASSESS THE IMPACT OF LONGO¿S PROCEDURE ON STOOL CONTINENCE AND ANORECTAL FUNCTION. FROM 1999 TO 2005, A TOTAL OF 242 PATIENTS (100 FEMALE AND 142 MALE PATIENTS; AGE RANGE: 29 TO 94 YEARS) UNDERWENT STAPLED HEMORRHOIDOPEXY FOR SYMPTOMATIC HEMORRHOIDAL PROLAPSE. DURING THE SURGICAL PROCEDURE, THE ANUS IS GENTLY DILATED BY USING THE OBTURATOR. PERIANAL TRACTION SUTURES ARE INSERTED AT 3, 6, 9 AND 12 O¿CLOCK TO FIX THE CAD 33 CIRCULAR ANAL DILATATOR (ETHICON). BY MEANS OF A PSA 33 SPECIAL SIDE OPEN ANOSCOPE (ETHICON), A PURSE STRING SUTURE IS INSERTED INTO THE MUCOUS MEMBRANE OF THE DISTAL RECTUM, ABOUT 2¿3 CM ABOVE THE HEMORRHOIDAL TISSUE. USING A PPH 0

  Patient problems: Blood Loss; Itching Sensation; No Code Available; Pain

  MAUDE report 8860587 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: LOW HEMORRHOIDOPEXY STAPLE LINE DOES NOT IMPROVE RESULTS AND INCREASES RISK FOR INCONTINENCE. AUTHORS: F. PIGOT, M. DAO-QUANG, A. CASTINEL, F. JUGUET, D. BOUCHARD, J. BOCKLE AND F.A. ALLAERT. CITATION: TECH COLOPROCTOL (2006) 10:329¿333; DOI 10.1007/S10151-006-0302-1; PUBLISHED ONLINE: 27 NOVEMBER 2006. THIS PROSPECTIVE STUDY AIMED TO ASSESS THE ASSOCIATION BETWEEN OUTCOME OF SH AND PATIENTS¿ CHARACTERISTICS AND PROCEDURE PARAMETERS (ASSOCIATED PROCEDURE, SUTURE LINE HEIGHT, DOUGHNUT SIZE, PRESENCE OF MALPIGHIAN TISSUE OR SMOOTH MUSCLE IN SPECIMEN). BETWEEN DECEMBER 2003 AND JUNE 2004, 68 PATIENTS WITH MEAN AGE 51 YEARS, RANGE 25-83 YEARS (MALE N=56, FEMALE N=12) UNDERWENT SH. A MUCOSAL DOUGHNUT WAS RESECTED JUST ABOVE THE APEX OF THE INTERNAL HEMORRHOIDS WITH A CIRCULAR STAPLER (PPH 01 OR 03, ETHICON ENDOSURGERY). EARLY COMPLICATIONS INCLUDED POSTOPERATIVE FISSURE (N=1) WHICH REQUIRED REOPERATION, LOCAL SEPSIS (N=2) WHICH REQUIRED OPERATION AND RECTAL BLEEDING (N=2) WHICH WAS MEDICALLY MANAGED WITHOUT BLOOD TRANSFUSION. THERE WAS PEROPERATIVE DYSFUNCTION OF THE STAPLER (N=1) WHICH WAS CORRECTED WITH MANUAL MUCOSAL ANASTOMOSIS. AT 4-WEEK FOL

  Patient problems: Blood Loss; Incontinence; No Code Available; Pain; Sepsis

  MAUDE report 8860235 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: PRIMARY AND REPEATED STAPLED HEMORRHOIDOPEXY FOR PROLAPSING HEMORRHOIDS: FOLLOW-UP TO FIVE YEARS. AUTHORS: DENNIS RAAHAVE, M.D., D.M.SCI., LARS V. JEPSEN, M.D. AND IB K. PEDERSEN, M.D. CITATION: DISEASES OF THE COLON AND RECTUM; VOLUME 51: 334¿341 (2008); DOI: 10.1007/S10350-007-9102-6. THIS STUDY WAS DESIGNED TO ASSESS INITIAL RESULTS, ANALYZE COMPLICATIONS AND FAILURES, AND DOCUMENT BOTH THE NEED FOR REPEATED PROCEDURES AND THE OUTCOMES OF FOLLOW-UP TO FIVE YEARS OF STAPLED HEMORRHOIDOPEXY. BETWEEN JUNE 8, 1999, AND MARCH 21, 2004, 258 PATIENTS (MALE=115, MEDIAN AGE 55, RANGE 29-83 YEARS AND FEMALE N=143, MEDIAN AGE 52, RANGE 23-87 YEARS) WITH SECOND-DEGREE, THIRD-DEGREE, OR FOURTH-DEGREE HEMORRHOIDS UNDERWENT MODIFIED STAPLED HEMORRHOIDOPEXY. AFTER STRETCHING THE ANORECTAL MUCOSA WITH FORCEPS, A MONOCRYL 2-0 PURSESTRING SUTURE WAS PLACED IN THE DEEP SUBMUCOSA, APPROXIMATELY 3 CM ABOVE THE DENTATE LINE, STARTING AT THE 8 O¿CLOCK POSITION AND TAKING THE SUTURE ANOSCOPE IN AND OUT CLOCKWISE THROUGH THE ANOSCOPE FOR EVERY STITCH. THE STAPLERS USED WERE THE EEA IN 12.7 PERCENT (TYCOHEALTHCARE, NEW HAVEN, CT) AND THE HCS 33 AND PPH01 (ETHICON E

  Patient problems: Blood Loss; Fistula; No Code Available; Pain

  MAUDE report 8860137 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED TRANSANAL RECTAL RESECTION TO TREAT OBSTRUCTED DEFECATION CAUSED BY RECTAL INTUSSUSCEPTION AND RECTOCELE. AUTHOR/S: A. RENZI, D. IZZO, G. DI SARNO, G. IZZO, N. DI MARTINO. CITATION: INT J COLORECTAL DIS (2006); 21: 661¿667. DOI 10.1007/S00384-005-0066-5. THIS STUDY WAS DESIGNED TO DETERMINE THE SAFETY AND EFFICACY OF A MODIFIED STAPLED TRANSANAL RECTAL RESECTION (STARR) IN PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME (ODS) CAUSED BY RECTAL-INTUSSUSCEPTION (RI) AND/OR RECTOCELE (RE). ALL THE PATIENTS WHO UNDERWENT STARR FOR ODS CAUSED RI AND/OR RE WERE PROSPECTIVELY INTRODUCED INTO A DATABASE. BETWEEN JUNE 2002 AND FEBRUARY 2004, 68 PATIENTS (3 MALE AND 65 FEMALE; MEAN AGE: 48.8±13.4 YEARS; AGE RANGE: 23¿77) WITH ODS WERE OBSERVED. THE MODIFIED STARR PROCEDURE PROPOSED REPRODUCES THE SURGICAL TECHNIQUE PROPOSED BY ANTONIO LONGO EVEN IF SOME MODIFICATIONS WERE SUGGESTED. TWO PPH-01 KITS (ETHICON) WERE UTILIZED. REPORTED COMPLICATION INCLUDED FAILED TO APPOSE METALLIC AGRAPHES (N-1) IN WHICH A HANDMADE SUTURE WAS NECESSARY TO COMPLETE THE RETRORECTAL ANASTOMOSIS. EARLY COMPLICATIONS INCLUDED MILD PERINEAL HEMATOMA (N-16) AND BLEEDING (N

  Patient problems: Blood Loss; Hematoma; Incontinence; No Code Available; Pain

  MAUDE report 8859848 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: RANDOMIZED CLINICAL TRIAL OF SYMPTOM CONTROL AFTER STAPLED ANOPEXY OR DIATHERMY EXCISION FOR HAEMORRHOID PROLAPSE AUTHORS: P.-O. NYSTROM, N. QVIST, D. RAAHAVE, I. LINDSEY, N. MORTENSEN, ON BEHALF OF THE STAPLED OR OPEN PILE PROCEDURE (STOPP) TRIAL STUDY GROUP CITATION: BRITISH JOURNAL OF SURGERY. 2010; 97: 167¿176. DOI: 10.1002/BJS.6804. THIS MULTICENTER RANDOMIZED CLINICAL TRIAL STUDIED HOW SYMPTOMS IMPROVED AFTER EITHER STAPLED ANOPEXY OR DIATHERMY EXCISION OF HEMORRHOIDS. THIS STUDY INVOLVED 207 PATIENTS THAT WERE RANDOMIZED TO EITHER ANOPEXY (AGE RANGE: 21 TO 86 YEARS OLD; 47 MALE AND 43 FEMALE PATIENTS) OR MILLIGAN-MORGAN HEMORRHOIDECTOMY, OF WHOM 90 IN EACH GROUP WERE OPERATED ON. FOR ANOPEXY CASES, A PPH01 33-MM STAPLING DEVICE (ETHICON) AND KIT UTENSILS WERE USED. IN THE ANOPEXY GROUP, REPORTED COMPLICATIONS INCLUDED, DAILY PAIN (N-25.2), PEAK PAIN (N-41.7), EXCESSIVE OR PROTRACTED PAIN (N-2), EXCESSIVE DISTURBANCE OF BOWEL DISFUNCTION (N-14), POST-OPERATIVE BLEEDING (N-5) WHICH REQUIRED REOPERATION IN 1 PATIENT, ANAL STENOSIS (N-1) AND WAS DILATED, THROMBOSED RESIDUAL HEMORRHOID (N-3) WHICH REQUIRED EXCISION IN 2 PATIENTS, FISSURE (

  Patient problems: Blood Loss; No Code Available; Pain; Thrombosis

  MAUDE report 8856562 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: NEW APPROACH TO LARGE HAEMORRHOIDAL PROLAPSE: DOUBLE STAPLED HAEMORRHOIDOPEXY. AUTHORS: GABRIELE NALDINI, JACOPO MARTELLUCCI, PASQUALE TALENTO, ANGELO CAVIGLIA, LUCA MORALDI, MAURO ROSSI. CITATION: INT J COLORECTAL DIS (2009); 24:1383¿1387. DOI: 10.1007/S00384-009-0750-Y. THE AIMS OF THIS STUDY WERE TO VERIFY IF IN LARGE HAEMORRHOIDAL PROLAPSES (INDEPENDENT FROM DEGREE) IN PATIENTS WITH NO SYMPTOMS OF OBSTRUCTED DEFAECATION SYNDROME (ODS), THE USE OF A STAPLED HAEMORRHOIDOPEXY VARIANT, COMPRISING A DOUBLE STAPLER HAEMORRHOIDOPEXY (DSH), MAKES IT POSSIBLE TO REDUCE THE PERCENTAGE OF FAILURES OR RELAPSES; AND TO STANDARDISE AN OBJECTIVE INTRAOPERATIVE PARAMETER FOR THE PURPOSE OF QUANTIFYING INTERNAL PROLAPSES WHICH CAN THEN BE USED AS A GUIDE IN DETERMINING THE TYPE OF TREATMENT TO BE PROVIDED. BETWEEN JUNE 2003 AND JUNE 2004, 353 PATIENTS (97 MALE AND 256 FEMALE; MEAN AGE: 47; AGE RANGE: 20-76) WERE OPERATED IN THREE CENTRES FOR HAEMORRHOIDAL PROLAPSE. THE OCCUPATION OF MORE THAN HALF OF THE LENGTH OF THE CIRCULAR ANAL DILATOR (CAD) OF A SET PPH 01 (ETHICON) BY PROLAPSE DURING THE EVALUATION UNDER ANAESTHESIA WAS TAKEN AS AN OBJECTIVE PARAME

  Patient problems: Blood Loss; Hematoma; No Code Available

  MAUDE report 8855961 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED HEMORRHOIDOPEXY VS. DIATHERMY EXCISION FOR FOURTH-DEGREE. HEMORRHOIDS: A RANDOMIZED, CLINICAL. TRIAL AND REVIEW OF THE LITERATURE. AUTHOR : HECTOR ORTIZ, JOSE MARXO , PEDRO ARMENDARIZ, MARIO DE MIGUEL. CITATION: DIS COLON RECTUM (2005); 48: 809¿815. DOI: 10.1007/S10350-004-0861-Z. THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE RESULTS OF STAPLED HEMORRHOIDOPEXY WITH THOSE OF CONVENTIONAL DIATHERMY EXCISION FOR CONTROLLING SYMPTOMS IN PATIENTS WITH FOURTH-DEGREE HEMORRHOIDS. BETWEEN JANUARY 2001 AND FEBRUARY 2002, 31 CONSECUTIVE PATIENTS WITH FOURTH-DEGREE HEMORRHOIDS WERE ENROLLED IN THE STUDY. THE PATIENTS WERE RANDOMIZED INTO TWO GROUPS: 15 PATIENTS (8 MALE AND 7 FEMALE; MEAN AGE: 47 YEARS; AGE RANGE: 28-69 YEARS) UNDERWENT STAPLED HEMORRHOIDOPEXY AND 16 PATIENTS (11 MALE AND 5 FEMALE; MEAN AGE: 49 YEARS; AGE RANGE: 32-69 YEARS) UNDERWENT DIATHERMY EXCISION. IN STAPLED HEMORRHOIDOPEXY, THE STAPLING PROCEDURE WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED BY LONGO. THE PPH01 STAPLING GUN (ETHICON) WAS OPENED TO ITS MAXIMUM POSITION AND INTRODUCED THROUGH THE ANUS. A PURSESTRING SUTURE WAS TIED ON THE STAPLER SHAFT, AND THE

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; No Code Available; Pain; Thrombosis

  MAUDE report 8845188 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED TRANSANAL RECTAL RESECTION (STARR): A NEW OPTION IN THE TREATMENT OF OBSTRUCTIVE DEFECATION SYNDROME. AUTHOR/S: A. OMMER, K. ALBRECHT ,F. WENGER , M. K. WALZ. CITATION: LANGENBECKS ARCH SURG (2006); 391: 32¿37. DOI 10.1007/S00423-005-0004-6. THE AIM OF THIS PROSPECTIVE STUDY WAS TO SHOW THE RESULTS OF THE NEW PROCEDURE STAPLED TRANSANAL¿RECTAL RESECTION (STARR). WITHIN THE SCOPE OF A PROSPECTIVE STUDY, FROM JANUARY 2003 TO JUNE 2005, 14 CONSECUTIVE PATIENTS (2 MALE AND 12 FEMALE; MEAN AGE 53±12 YEARS; AGE RANGE: 28¿74 YEARS) UNDERWENT STAPLED TRANSANAL RECTAL RESECTION OF THE RECTAL WALL. THE OPERATIVE TECHNIQUE IN ALL CASES WAS A MODIFICATION OF THE STAPLED HEMORRHOIDOPEXY BASED ON THE LONGO PROCEDURE USING PPH01 (ETHICON). REPORTED COMPLICATIONS INCLUDED SECONDARY HEMORRHAGE FROM THE STAPLE ROW (N-2) WHICH COULD BE CONTROLLED BY DIRECT TRANSANAL SUTURE UNDER GENERAL ANESTHESIA, SMALL AND ASYMPTOMATIC DEHISCENCE OF THE VENTRAL STAPLER ROW (N-1) WHICH HEALED UP WITHOUT SEQUENCE, SEVERE ANAL PAIN (N-1) WHICH SPONTANEOUSLY CEASED AFTER 4 WEEKS, PAIN ON OPERATION DAY (N-?) IN WHICH FIVE PATIENTS NEEDED ANALGETIC DRUGS SUCH AS MORPHINE,

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Incontinence; No Code Available; Pain

  MAUDE report 8843582 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: MID-TERM RESULTS OF STAPLED HEMORRHOIDOPEXY FOR THIRD- AND FOURTH-DEGREE HEMORRHOIDS¿CORRELATION WITH THE HISTOLOGICAL FEATURES OF THE RESECTED TISSUE. AUTHORS: GIL OHANA, BORIS MYSLOVATY, ARIE ARICHE, ZEEV DREZNIK, RUMELIA KOREN, LEA RATH-WOLFSON. CITATION: WORLD J SURG. 2007; 31: 1336¿1342. DOI: 10.1007/S00268-007-9048-9. STAPLED HEMORRHOIDOPEXY IS USED TO REMOVE A CIRCUMFERENTIAL STRIP OF MUCOSA AND SUBMUCOSA ABOUT 4 CM ABOVE THE DENTATE LINE, IN ORDER TO RESTORE THE CORRECT ANATOMICAL RELATIONSHIPS OF THE ANAL CANAL STRUCTURES. THE AUTHORS EVALUATED THE HISTOLOGICAL FEATURES OF THE RESECTED TISSUE OBTAINED AFTER STAPLED HEMORRHOIDOPEXY WITH CORRELATION TO THE SHORT-TERM AND MID-TERM RESULTS. THIS RETROSPECTIVE STUDY EVALUATED 234 CASES (81 FEMALE AND 153 MALE PATIENTS; AGE RANGE: 24 TO 89 YEARS OLD) OF STAPLED HEMORRHOIDOPEXY AND WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, A PPH01 33-MM CIRCULAR STAPLER (ETHICON) WAS USED ACCORDING TO THE SAME TECHNICAL GUIDELINES DESCRIBED IN THE LITERATURE FOR STAPLED HEMORRHOIDOPEXY. A PROLENE 2-0 PURSESTRING SUTURE (ETHICON) WAS PLACED 4 CM ABOVE THE DENTATE LINE. REPORTED COMPLICATION

  Patient problems: Abscess; Pain

  MAUDE report 8843574 ↗
• InjuryJul 30, 2019Failure to Form Staple

  TITLE: PROSPECTIVE RANDOMISED CLINICAL TRIAL OF SINGLE VERSUS DOUBLE PURSE-STRING STAPLED MUCOSECTOMY IN THE TREATMENT OF PROLAPSED HAEMORRHOIDS. AUTHORS: FRANCISCO PÉREZ-VICENTE, ANTONIO ARROYO, PILAR SERRANO, FERNANDO CANDELA, ANA SANCHEZ AND RAFAEL CALPENA. CITATION: INT J COLORECTAL DIS (2006) 21: 38¿43; DOI 10.1007/S00384-004-0720-3; PUBLISHED ONLINE: 21 APRIL 2005. THIS PROSPECTIVE RANDOMIZED CLINICAL TRIAL AIMED TO COMPARE THE OUTCOMES AFTER SINGLE PURSE-STRING CSM VERSUS DOUBLE PURSE-STRING CSM. BETWEEN MAY 2000 AND JUNE 2002, ONE HUNDRED CONSECUTIVE PATIENTS (MALE N=63, FEMALE N=37, MEAN AGE 50.70 YEARS) WERE RANDOMIZED TO SINGLE PURSE-STRING CSM (GROUP 1, N=50, MALE N=34, FEMALE N=16, WITH MEAN AGE 49.50 YEARS) VERSUS DOUBLE PURSE-STRING CSM (GROUP 2, N=50, MALE N=29, FEMALE N=21, WITH MEAN AGE 51.92 YEARS. THE OPERATION WAS CARRIED OUT ACCORDING TO THE TECHNIQUE INITIALLY DESCRIBED BY LONGO UTILIZING A 33-MM CIRCULAR STAPLING DEVICE (PPH 33-01, ETHICON ENDOSURGERY). COMPLICATIONS IN THE SINGLE PURSE GROUP INCLUDED ANASTOMOTIC BLEEDING REQUIRING TRANSFIXIVE SUTURE (N=14), STAPLE SUTURE DEFECT (N=2), PAIN ON DEFECATION (N=14), FREQUENT BLEEDING POSTOPERATIVE (N=7), DAILY B

  Patient problems: Blood Loss; Incontinence; No Code Available; Pain

  MAUDE report 8843568 ↗
• InjuryJul 30, 2019Failure to Form Staple

  IT WAS REPORTED VIA LITERATURE ENTITLED: LONG-TERM RESULTS AFTER STAPLED HEMORRHOIDOPEXY: A PROSPECTIVE STUDY WITH A 6-YEAR FOLLOW-UP. AUTHORS: A. OMMER, M.D., JAKOB HINRICHS, M.D., HORST MOLLENBERG, M.D., BABJI MARLA, M.D., MARTIN KARL WALZ, M.D. CITATION: DIS COLON RECTUM (2011); 54: 601¿608. DOI: 10.1007/DCR.0B013E3182098DF2. THE STUDY INCLUDED CONSECUTIVE PATIENTS WHO UNDERWENT STAPLED HEMORRHOIDOPEXY AT OUR INSTITUTION FROM MAY 27, 1999, THROUGH DECEMBER 31, 2003. STAPLED HEMORRHOIDOPEXY WAS PERFORMED IN 257 CONSECUTIVE PATIENTS (175 MALE AND 82 FEMALE; MEAN AGE: 53 ±13; AGE RANGE: 19-88 YEARS) WITH GRADE III HEMORRHOIDS. THE OPERATING PROCEDURE WAS PERFORMED WITH A PPH-01 STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED PARTIAL DEHISCENCE (N-3) IN WHICH THE ROW OF STAPLES HAD TO BE OVER SEWN WITH INTERRUPTED SUTURES, RESIDUAL HEMORRHOIDAL NODULES THAT HAD NOT BEEN PERFECTLY REPOSITIONED (N-18) WHICH WERE REMOVED BY CONVENTIONAL RESECTION, BLEEDING COMPLICATIONS (N-10) REQUIRING SURGICAL INTERVENTION, HEMORRHOIDAL THROMBOSIS (N-1) IN WHICH THE PATIENT HAD A REOPERATION, INCOMPLETE REPOSITIONING (N-1) IN WHICH THE PATIENT RECEIVED VENTRAL MUCOSECTOMY, VENTRAL STAPLE WAS SPLIT

  Patient problems: Blood Loss; Itching Sensation; No Code Available; Pain; Thrombosis

  MAUDE report 8843559 ↗
• InjuryJul 30, 2019Failure to Form Staple

  IT WAS REPORTED VIA LITERATURE ENTITLED: PELVIC SEPSIS AFTER STAPLED HEMORRHOIDECTOMY AUTHORS: PATRICK PESSAUX, MD; EMILIE LERMITE, MD; JEAN-JACQUES TUECH, MD; OLIVIER BREHANT, MD; NICOLAS REGENET, MD; JEAN-PIERRE ARNAUD, MD CITATION: J AM COLL SURG. 2004; 199(5): 824-5. DOI: 10.1016/J.JAMCOLLSURG.2004.04.026. A PREVIOUSLY HEALTHY (B)(6) YEAR-OLD MAN UNDERWENT STAPLED HEMORRHOIDECTOMY DONE WITH PPH 01 33-MM ETHICON HEMORRHOIDAL CIRCULAR STAPLER (ETHICON). FOUR DAYS LATER, THE PATIENT WAS PRESENTED BACK AT THE EMERGENCY DEPARTMENT COMPLAINING OF RECTAL DISCOMFORT AND PERINEAL PAIN. THE PATIENT HAD SEPTIC SHOCK AND FEVER OF 39.2 °C. PERINEAL EXAMINATION SHOWED EXTENSIVE SUBCUTANEOUS NECROSIS OF THE SCROTUM AND INGUINAL AREA WITH CREPITUS ON PALPATION. CT SHOWED A LEAKAGE FROM THE STAPLE LINE WITH EXTENSIVE GAS DEVELOPING THE RECTUM, BLADDER, AND SCROTUM. THE PATIENT UNDERWENT EMERGENCY SURGERY. THE RECTUM WAS INFLATED WITH WATER AND POVIDONE-IODINE. DEBRIDEMENT AND AN END-COLOSTOMY WERE PERFORMED. REPEAT NECROSECTOMY AND HYPERBARIC OXYGEN THERAPY WERE DONE DURING THE STAY. CULTURE OF THE NECROTIC TISSUE SHOWED A POLYMICROBIAL INFECTION (ESCHERICHIA COLI, BACTEROIDES FRAGILIS, AND ENT

  Patient problems: Fever; No Code Available; Pain; Septic Shock

  MAUDE report 8842960 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: LIFE THREATENING PELVIC SEPSIS AFTER STAPLED HAEMORRHOIDECTOMY. AUTHOR/S: RICHARD G MOLLOY, DAVID KINGSMORE. CITATION: THE LANCET ¿ VOL 355 ¿ MARCH 4, 2000; 810. THIS STUDY AIMED TO PRESENT A CASE OF (B)(6) YEAR-OLD MALE PATIENT WHO UNDERWENT DAY-CASE STAPLED HAEMORRHOIDECTOMY WITH 33-MM PPH 01 STAPLING GUN, ETHICON, AND DEVELOPED SEVERE PELVIC SEPSIS. IN THE EVENING OF THE SAME DAY OF HAEMORRHOIDECTOMY, HE DEVELOPED A TEMPERATURE OF 38.5°C AND WAS ADMITTED FOR OBSERVATION WITH INTRAVENOUS ANTIBIOTICS, BUT HIS CONDITION FAILED TO IMPROVE. HE ALSO COMPLAINED OF PERINEAL, PELVIC AND LOWER ABDOMINAL PAIN. COMPUTED TOMOGRAPHY SHOWED RETROPERITONEAL GAS ENVELOPING THE RECTUM. HE WAS SCHEDULE FOR EXPLORATORY LAPAROTOMY. AT OPERATION, THE PARARECTAL TISSUES WERE INFLAMED, OEDEMATOUS AND VASCULAR. AT A POINT LEVEL WITH THE STAPLE LINE, A SMALL POCKET OF PUS WAS SEEN. CULTURE OF THE PUS SHOWED HEAVY GROWTH OF LACTOSE FERMENTING COLIFORMS, BACTEROIDES FRAGILIS AND A CLOSTRIDIUM (NOT C TETANI OR C PERFRINGENS). HE MADE AN UNCOMPLICATED RECOVERY AND WAS DISCHARGE 14 DAYS AFTER HIS HAEMORRHOIDECTOMY. IN SUCH CIRCUMSTANCES, INFECTION, IF PRESENT, MIGHT PR

  Patient problems: Abdominal Pain; Edema; Inflammation; No Code Available; Not Applicable; Sepsis

  MAUDE report 8841308 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: EXPERIENCE OF 3711 STAPLED HAEMORRHOIDECTOMY OPERATIONS. AUTHORS: K.-H. NG, K.-S. HO, B.-S. OOI, C.-L. TANG AND K.-W. EU. CITATION: BRITISH JOURNAL OF SURGERY (2006); 93: 226¿230. DOI: 10.1002/BJS.5214. THE AIM OF THIS STUDY WAS TO REVIEW RETROSPECTIVELY THE EFFECTIVENESS AND EFFICIENCY OF STAPLED HAEMORRHOIDECTOMY. A RETROSPECTIVE REVIEW WAS UNDERTAKEN OF ALL PATIENTS WHO UNDERWENT STAPLED HAEMORRHOIDECTOMY BETWEEN OCTOBER 1999 AND MAY 2004. A TOTAL OF 3711 PATIENTS (48.9% MALE AND 51.1% FEMALE; MEDIAN AGE: 50; AGE RANGE: 18-88 YEARS) HAD THE SURGERY. STAPLED HAEMORRHOIDECTOMY WAS PERFORMED USING A MODIFICATION OF THE LONGO TECHNIQUE, WITH A PPH01 STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N-160) IN WHICH 27 PATIENTS REQUIRED BLOOD TRANSFUSION, 66 PATIENTS HAD A SUBMUCOSAL ADRENALINE INJECTIONS BEING SUCCESSFUL IN 62 PATIENTS, 16 PATIENTS REQUIRED SURGICAL HEMOSTASIS, AND IN 81 PATIENTS, THE BLEEDING STOPPED WITHOUT INTERVENTION, SIGNIFICANT POSTOPERATIVE PAIN (N-57) IN WHICH THE PATIENTS WERE READMITTED AND WERE TREATED CONSERVATIVELY WITH ANALGESIA, ANORECTAL STRICTURE (N-52) REQUIRING INTERVENTION OF STRIC

  Patient problems: Abscess; Blood Loss; Failure to Anastomose; Hematoma; No Code Available; Pain; Sepsis; Thrombosis

  MAUDE report 8840739 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED HEMORRHOIDOPEXY: A PROSPECTIVE STUDY FROM PATHOLOGY TO CLINICAL OUTCOME AUTHORS: PIERPAOLO SILERI, VITO MARIA STOLFI, GIAMPIERO PALMIERI, ALESSANDRA MELE, ALESSANDRO FALCHETTI, SARA DI CARLO, ACHILLE LUCIO GASPARI CITATION: J GASTROINTEST SURG (2007) 11:1662¿1668. DOI: 10.1007/S11605-007-0328-3. THE AUTHORS REPORT THEIR EXPERIENCE WITH THE TECHNIQUE AND CORRELATE PATHOLOGICAL FINDINGS TO SHORT- AND LONG-TERM CLINICAL OUTCOMES. BETWEEN JANUARY 2003 AND APRIL 2007, 94 SYMPTOMATIC PATIENTS (56 MALE AND 38 FEMALE; AGE RANGE: 21-75 YEARS) UNDERWENT HEMORRHOIDOPEXY IN A DAY-SURGERY SETTING. THE PROCEDURE WAS PERFORMED USING THE PPH01 KIT (ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE FEVER (>38°C) (N-5), POSTOPERATIVE PAIN AT 1 WEEK (N-48), POSTOPERATIVE PAIN AT 1 MONTH (N-20), POSTOPERATIVE PAIN AT 3 MONTHS (N-11), POSTOPERATIVE PAIN AT 1 YEAR (N-3), BLEEDING AT 1 WEEK (N-26) AND BLEEDING AT 1 MONTH (N-9) IN WHICH 3 PATIENTS WERE ADMITTED, AND A FOLEY CATHETER WAS INSERTED INTO THE ANORECTAL CANAL TO COMPRESS THE BLEEDING VESSELS AND 1 PATIENT FURTHER REQUIRED SURGICAL REVISION, BLEEDING AT 3 MONTHS (N-7), SOILING AT 1 WEEK (N-2

  Patient problems: Blood Loss; No Code Available; Pain; Thrombosis

  MAUDE report 8830846 ↗