Contour Transtar STR5GRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705036002871), received between Dec 7, 2017 and Dec 12, 2022 — classified as 51 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LOW ANTERIOR RESECTION SYNDROME FOLLOWING DIFFERENT SURGICAL APPROACHES FOR LOW RECTAL ENDOMETRIOSIS: A RETROSPECTIVE MULTICENTER STUDY AUTHOR: ATTILA BOKOR1* / GERNOT HUDELIST2* / NOÉMI DOBÓ1 / BERNHARD DAUSER3 / MARILENA FARELLA4 / RÉKA BRUBEL1 / JEAN-JACQUES TUECH5 / HORACE ROMAN4,5 CITATION:ACTA OBSTET GYNECOL SCAND. 2021;100:860¿867. DOI: 10.1111/AOGS.14046. THIS RETROSPECTIVE INTERNATIONAL MULTICENTRIC COHORT STUDY AIMS TO COMPARE TWO SURGICAL APPROACHES (LAPAROSCOPIC-TRANSANAL DISK EXCISION (LTADE) AND NERVE- AND VESSEL-SPARING LIMITED SEGMENTAL RESECTION (NVSSR)) FOR FULL-THICKNESS EXCISION OF RECTAL DE WITH AN ANASTOMOTIC HEIGHT =7 CM DISTANCE FROM THE ANAL VERGE WITH REGARDS TO THE INCIDENCE OF LOW ANTERIOR RESECTION SYNDROME (LARS), POSTOPERATIVE OUTCOMES, AND FERTILITY RESULTS. BETWEEN OCTOBER 2009 AND DECEMBER 2018, A TOTAL OF 211 PATIENTS PREMENOPAUSAL WOMEN WITH DEEP INFILTRATING ENDOMETRIOSIS (DE) OF THE LOWER RECTUM WHO WERE SCHEDULED FOR SURGICAL TREATMENT IN THREE TERTIARY REFERRAL CENTERS (DEPARTMENT OF OBSTETRICS AND GYNECOLOGY AT ROUEN UNIVERSITY HOSPITAL, ROUEN, FRANCE; DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, SEMME

  Patient problems: Insufficient Information

  MAUDE report 15959891 ↗
• InjuryOct 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LOW ANTERIOR RESECTION SYNDROME FOLLOWING DIFFERENT SURGICAL APPROACHES FOR LOW RECTAL ENDOMETRIOSIS: A RETROSPECTIVE MULTICENTER STUDY. AUTHORS: ATTILA BOKOR, GERNOT HUDELIST2, NOÉMI DOBÓ, BERNHARD DAUSER, MARILENA FARELLA, RÉKA BRUBEL, JEAN-JACQUES TUECH, HORACE ROMAN. CITATION CITE: ACTA OBSTET GYNECOL SCAND. 2021;100:860¿867. DOI: 10.1111/AOGS.14046. THE AIM OF THE PRESENT WORK WAS TO COMPARE TWO SURGICAL APPROACHES (LTADE AND NVSSR) FOR FULL-THICKNESS EXCISION OF RECTAL DE WITH AN ANASTOMOTIC HEIGHT =7 CM DISTANCE FROM THE ANAL VERGE WITH REGARDS TO THE INCIDENCE OF LARS, POSTOPERATIVE OUTCOMES, AND FERTILITY RESULTS. A TOTAL OF 211 PATIENTS UNDERGOING RECTAL SURGERY FOR LOW DE (=7 CM FROM THE ANAL VERGE) IN THREE DIFFERENT TERTIARY REFERRAL CENTERS BETWEEN OCTOBER 2009 AND DECEMBER 2018 WERE RETROSPECTIVELY REVIEWED REGARDING MAJOR COMPLICATIONS AND LARS. FROM THE 211 ELIGIBLE PATIENTS, SIX WOMEN WERE EXCLUDED BECAUSE OF LOSS TO FOLLOW-UP. FINALLY, A TOTAL NUMBER OF 205 PATIENTS WERE ENROLLED FOR THE STATISTICAL ANALYSIS; 139 WITH NERVE- AND VESSEL-SPARING SEGMENTAL RESECTION (NVSSR) AND 66 OPERATED FOR LAPAROSCOPIC-TRANSANAL DISK E

  Patient problems: Insufficient Information

  MAUDE report 15624558 ↗
• InjuryMay 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LOW ANTERIOR RESECTION SYNDROME FOLLOWING DIFFERENT SURGICAL APPROACHES FOR LOW RECTAL ENDOMETRIOSIS: A RETROSPECTIVE MULTICENTER STUDY AUTHOR: ATTILA BOKOR1* / GERNOT HUDELIST2* / NOÉMI DOBÓ1 / BERNHARD DAUSER3 / MARILENA FARELLA4 / RÉKA BRUBEL1 / JEAN-JACQUES TUECH5 / HORACE ROMAN4,5 CITATION:ACTA OBSTET GYNECOL SCAND. 2021;100:860¿867. DOI: 10.1111/AOGS.14046. THIS RETROSPECTIVE INTERNATIONAL MULTICENTRIC COHORT STUDY AIMS TO COMPARE TWO SURGICAL APPROACHES (LAPAROSCOPIC-TRANSANAL DISK EXCISION (LTADE) AND NERVE- AND VESSEL-SPARING LIMITED SEGMENTAL RESECTION (NVSSR)) FOR FULL-THICKNESS EXCISION OF RECTAL DE WITH AN ANASTOMOTIC HEIGHT =7 CM DISTANCE FROM THE ANAL VERGE WITH REGARDS TO THE INCIDENCE OF LOW ANTERIOR RESECTION SYNDROME (LARS), POSTOPERATIVE OUTCOMES, AND FERTILITY RESULTS. BETWEEN OCTOBER 2009 AND DECEMBER 2018, A TOTAL OF 211 PATIENTS PREMENOPAUSAL WOMEN WITH DEEP INFILTRATING ENDOMETRIOSIS (DE) OF THE LOWER RECTUM WHO WERE SCHEDULED FOR SURGICAL TREATMENT IN THREE TERTIARY REFERRAL CENTERS (DEPARTMENT OF OBSTETRICS AND GYNECOLOGY AT ROUEN UNIVERSITY HOSPITAL, ROUEN, FRANCE; DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, SEMME

  Patient problems: Fistula; Insufficient Information

  MAUDE report 14434186 ↗
• InjuryFeb 9, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TRANS-STARR SURGERY BECAUSE OF RECTAL PROLAPSE III. THE STAPLES DID NOT CLOSE PROPERLY, AND THIS LED TO PERIANAL OPENING OF THE ENTEROCELE. PROCEDURE: RECTUM PROCEDURE.

  Patient problems: Failure to Anastomose

  MAUDE report 13498933 ↗
• MalfunctionJan 29, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AFTER RELOAD THE THORN COULD NOT BE EXTENDED. A NEW INSTRUMENT HAD TO BE OPENED. AFTER RELOADING, THE RETAINING PIN DID NOT COME OUT. A NEW DEVICE HAD TO BE OPENED. NO PATIENT HARM NOR SIGNIFICANT SURGICAL DELAY REPORTED. PROCEDURE RECTUM PROLAPSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252854 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROLAPSE, THE PATIENT HAS A FISTULA AFTER SURGERY.

  Patient problems: Fistula

  MAUDE report 9865168 ↗
• MalfunctionFeb 18, 2020Failure to Fire

  IT WAS REPORTED THAT DURING A TRANSTAR PROCEDURE, THE DEVICE DID NOT FIRE. NO MORE INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722650 ↗
• MalfunctionFeb 18, 2020Failure to Fire

  IT WAS REPORTED THAT DURING A TRANSTAR PROCEDURE, THE DEVICE DID NOT FIRE. NO MORE INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722613 ↗
• InjuryDec 9, 2019Failure to Cut

  IT WAS REPORTED THAT DURING A STARR PROCEDURE, THE DEVICE BLOCKED INTRAOPERATIVELY AND DID NOT TRIGGER. THE STAPLE LINE WAS DEPLOYED BUT THE DEVICE DID NOT CUT. DUE TO THE ISSUE WITH THE DEVICE IN THE SITUS, THE PATIENT ABDOMEN HAD TO BE OPENED. FURTHER PATIENT CONSEQUENCES ARE CURRENTLY UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9437133 ↗
• InjuryJul 20, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: LAPAROSCOPIC VENTRAL RECTOPEXY VERSUS STAPLED TRANSANAL RECTAL RESECTION FOR TREATMENT OF OBSTRUCTED DEFECATION IN THE ELDERLY: LONG-TERM RESULTS OF A PROSPECTIVE RANDOMIZED STUDY. AUTHORS: KHALED M. MADBOULY, M.D., PH.D., F.R.C.S.(GLASG.), AHMED D. MOHII, M.D. CITATION: DISEASE OF THE COLON AND RECTUM (2019); 62(1):47-55. DOI: 10.1097/DCR.0000000000001256. THE PURPOSE OF THIS STUDY WAS TO COMPARE LONG-TERM FUNCTIONAL OUTCOME, RECURRENCE RATE, AND QUALITY OF LIFE BETWEEN LAPAROSCOPIC VENTRAL RECTOPEXY AND STAPLED TRANSANAL RECTAL RESECTION IN THE TREATMENT OF OBSTRUCTED DEFECATION. THIS PROSPECTIVE RANDOMIZED STUDY INCLUDED 112 PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME (ODS) ATTRIBUTED TO RECTOCELE OR INTERNAL RECTAL INTUSSUSCEPTION FROM MAY 2013 TO APRIL 2016. PATIENTS WERE RANDOMLY ALLOCATED TO GROUP 1, 56 PATIENTS (11 MALE AND 45 FEMALE; AGE RANGE: 70-85 YEARS; BMI: 28.3 ± 3.4) UNDERWENT LAPAROSCOPIC VENTRAL RECTOPEXY (LVR), OR GROUP 2, 56 PATIENTS (18 MALE AND 38 FEMALE; AGE RANGE: 70-85 YEARS; BMI: 29.1 ± 4.5) UNDERWENT STAPLED TRANSANAL RECTAL RESECTION (STARR). IN GROUP 2, PATIENTS HAD MODIFIED PERINEAL STAPLED RECTAL RESECTION WIT

  Patient problems: Blood Loss; Incontinence; Obstruction/Occlusion; Pain

  MAUDE report 8809905 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STARR WITH CONTOUR® TRANSTAR¿ DEVICE FOR OBSTRUCTED DEFECATION SYNDROME: ONE-YEAR REAL-WORLD OUTCOMES OF THE EUROPEAN TRANSTAR REGISTRY. AUTHORS: G. RIBARIC, A. D¿HOORE, G. SCHIFFHORST AND E. HEMPEL. CITATION: INT J COLORECTAL DIS (2014) 29:611¿622; DOI 10.1007/S00384-014-1836-8; PUBLISHED ONLINE: 21 FEBRUARY 2014. THIS PROSPECTIVE COHORT STUDY AIMED TO ASSESS THE SHORT-TERM SAFETY AND EFFECTIVENESS OF TRANSTAR IN THE REAL-WORLD CLINICAL ENVIRONMENT WHERE THE VARIATION PHENOMENON EXISTS. BETWEEN JANUARY 2009 TO JANUARY 2011, 100 PATIENTS (MEAN AGE 60 YEARS, RANGE 27-82, FEMALE N=98, MALE N=2) WITH ODS UNDERWENT TRANSTAR. THE CONTOUR TRANSTAR STAPLING KIT (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA) WAS OPENED AND THE CIRCULAR ANAL DILATOR (CAD) WAS GENTLY INTRODUCED AND FIXED TO THE PERIANAL SKIN WITH FOUR CARDINAL SUTURES. A SWAB WAS INSERTED AND GENTLY PULLED OUTWARD TO VISUALIZE THE APEX OF THE INTUSSUSCEPTION. FINALLY, THE TRANSTAR TECHNIQUE WAS PERFORMED IN THREE STEPS: STEP 1: PARACHUTE SUTURE PLACEMENT, STEP 2: OPENING OF THE PROLAPSE, AND STEP 3: CIRCUMFERENTIAL RESECTION. INTRAOPERATIVE COMPLICATIONS INCLUDED PARTIAL DEHISCENCE

  Patient problems: Blood Loss; No Code Available; No Consequences Or Impact To Patient; Pain; Urinary Retention

  MAUDE report 8808543 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: SEVERE MESORECTAL BLEEDING AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR-OPERATION) USING THE CONTOUR TRANSTAR CURVED CUTTER STAPLER. AUTHOR: M. GELOS, K. FROMMHOLD AND B. MANN. CITATION: THE AUTHORS. JOURNAL COMPILATION 2010 THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. COLORECTAL DISEASE, 12, 261¿266; DOI:10.1111/J.1463-1318.2009.01965.X. THIS CASE REPORT DESCRIBES A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED WITH A 10-YEAR HISTORY OF WORSENING OUTLET OBSTRUCTION. SHE COMPLAINED OF INCOMPLETE EVACUATION, HAD USED PERINEAL SUPPORT AND INSERTED FINGERS INTO THE VAGINA FOR EVACUATION. PROCTOSCOPIC EXAMINATION REVEALED A LARGE RECTOCELE AND A GOOD SPHINCTER PRESSURE. DEFECOGRAPHY SHOWED A TYPE I RECTOCELE WITH A SIZE MORE THAN 4 CM. STAPLED TRANSANAL RECTAL RESECTION BY MEANS OF THE CONTOUR TRANSTAR WAS PERFORMED. FORTY-SEVEN GRAMS OF RECTAL TISSUE WAS REMOVED USING SIX RELOADED STAPLER CARTRIDGES. DIGITAL EXAMINATION REVEALED THAT THE RECTOCELE WAS COMPLETELY REMOVED. ON THE FIRST POSTOPERATIVE DAY, THE PATIENT COMPLAINED OF ACUTE PELVIC AND ABDOMINAL PAIN. CLINICALLY, PERITONISM OF THE LOWER ABDOMEN WAS FOUND. COMPUTED TOMO

  Patient problems: Abdominal Pain; Hematoma; No Code Available; Pain

  MAUDE report 8806817 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: TITLE : COMBINED TRANSANAL AND LAPAROSCOPIC APPROACH FOR THE TREATMENT OF DEEP ENDOMETRIOSIS INFILTRATING THE RECTUM AUTHOR: VALE´ RIE BRIDOUX, HORACE ROMAN2,,*, BABAK KIANIFARD1, MAUD VASSILIEFF2, LOI¨C MARPEAU2, FRANCIS MICHOT1,, AND JEAN-JACQUES TUECH CITATION: HUMAN REPRODUCTION, VOL.27, NO.2 PP. 418¿426, 2012; DOI:10.1093/HUMREP/DER422. THIS RETROSPECTIVE STUDY AIMED TO DESCRIBE A NEW TECHNIQUE FOR TRANSANAL FULL THICKNESS DISC EXCISION OF ENDOMETRIOTIC NODULES INFILTRATING THE LOW AND MIDDLE RECTUM, USING THE CONTOUR TRANSTAR STAPLER AND TO PRESENT DATA ON THE FEASIBILITY OF THIS TECHNIQUE AS AN EFFECTIVE TOOL IN THE SURGICAL MANAGEMENT OF DIER. FROM APRIL 2009 TO OCTOBER 2010, SIX NULLIPAROUS WOMEN (AGED FROM 25 TO 31 YEARS OLD) WERE SURGICALLY MANAGED FOR SYMPTOMATIC DIER. THE FIRST STEP IS PERFORMED LAPAROSCOPICALLY. BOTH PARARECTAL SPACES ARE OPENED BELOW THE LATERAL LIMITS OF THE RECTAL NODULE, THE RECTOVAGINAL SPACE IS REACHED BELOW THE INFERIOR LIMIT OF THE NODULE AND THE NODULE IS DISSECTED AWAY FROM THE RECTAL WALL, USING THE ULTRACISION HARMONIC SCALPEL (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). A TRANSAN

  Patient problems: Pain

  MAUDE report 8799764 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PELVIC FLOOR FUNCTION FOLLOWING VENTRAL RECTOPEXY VERSUS STARR IN THE TREATMENT OF OBSTRUCTED DEFECATION. AUTHOR/S: D. F. ALTOMARE, A. PICCIARIELLO, R. MEMEO, M. FANELLI, R. DIGENNARO, N. CHETTA, M. DE FAZIO. CITATION: TECHNIQUES IN COLOPROCTOLOGY (2018) 22: 289¿294; HTTPS://DOI.ORG/10.1007/S10151-018-1776-3; PUBLISHED ONLINE: 28 MARCH 2018. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE FUNCTIONAL OUTCOME OF STAPLED TRANSANAL RECTAL RESECTION (STARR) AND VENTRAL RECTOPEXY (VRP) IN A SERIES OF ODS PATIENTS, WITH REGARD NOT ONLY TO DEFECATION BUT ALSO TO OVERALL PELVIC FLOOR FUNCTION. BETWEEN 2006 TO 2016, FORTY-NINE FEMALE PATIENTS WHO HAD SURGERY FOR ODS WERE EVALUATED. TWENTY-EIGHT PATIENTS (MEDIAN AGE 60, RANGE 54-69 YEARS) HAD VRP AND 21 PATIENTS (MEDIAN AGE 58 RANGE 51-66 YEARS) HAD STARR. VENTRAL RECTOPEXY (VRP) WAS PERFORMED BY LAPAROSCOPY, USING RESORBABLE (BIOLOGICAL) OR UNRESORBABLE MESHES. STAPLED TRANSANAL RECTAL RESECTION (STARR) WAS DONE BY RESECTION OF THE RECTOCELE AND THE RECTAL INTUSSUSCEPTION BY TWO CIRCULAR STAPLERS (PPH01 ETHICON ENDOSURGERY) OR A RECHARGEABLE CURVED LINEAR STAPLER (CONTOUR TRANSTAR, ETHICON ENDOSURGER

  Patient problems: Incontinence; No Consequences Or Impact To Patient; Obstruction/Occlusion; Pain

  MAUDE report 8799239 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem

  TITLE : DOUBLE PPH TECHNIQUE FOR HEMORRHOIDAL PROLAPSE: A MULTICENTRIC, PROSPECTIVE, AND NONRANDOMIZED TRIAL AUTHOR : A. BRAINI, MD, P. NARISETTY, MD , A. FAVERO, MD, S. CALANDRA, MD, A. CALANDRA, MD, F. CAPONNETTO, MD, F. DIGITO, MD, F. DA POZZO, MD, E. MARCOTTI, MD, E. POREBSKI, MD, S. ROVEDO, MD, G. TERROSU, MD, L. TORRICELLI, MD, AND A. STUTO, MD CITATION: DOI: 10.1177/1553350612472988. LONGO¿S TECHNIQUE (OR PPH TECHNIQUE) IS WELL KNOWN WORLDWIDE. ONE OF THE REASONS FOR THE RECURRENCE IS THE TREATMENT OF THE ADVANCED HEMORRHOIDAL PROLAPSE WITH A SINGLE STAPLING DEVICE, WHICH IS NOT ENOUGH TO RESECT THE APPROPRIATE AMOUNT OF PROLAPSE. THE AUTHORS DESCRIBED THE APPLICATION OF ¿DOUBLE PPH TECHNIQUE¿ (D-PPH) TO TREAT LARGE HEMORRHOIDAL PROLAPSES. THE AUTHORS PERFORMED A MULTICENTRIC, PROSPECTIVE, AND NONRANDOMIZED TRIAL FROM JULY 2008 TO JULY 2009. A TOTAL OF 281 PATIENTS (142 MALE AND 65 FEMALE PATIENTS; AGE RANGE: 23 TO 79 YEARS OLD) WITH HEMORRHOIDAL PROLAPSE UNDERWENT SURGERY AND WERE INCLUDED IN THE STUDY. OF WHICH, 74 PATIENTS WERE ASSIGNED TO THE D-PPH GROUP AND 207 PATIENTS UNDERWENT SINGLE PPH. DURING THE OPERATIVE TECHNIQUE, THE STEPS OF D-PPH IS THE SAME AS THE LONGO¿S T

  Patient problems: Blood Loss; No Code Available; Pain

  MAUDE report 8730937 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: EMERGING TECHNOLOGIES IN COLOPROCTOLOGY: RESULTS OF THE ITALIAN SOCIETY OF COLORECTAL SURGERY LOGBOOK OF ADVERSE EVENTS. AUTHOR : L. BASSO, M. PESCATORI, F. LA TORRE, I. DESTEFANO, A. PULVIRENTI D¿URSO, A. INFANTINO, A. AMATO, AECO GROUP. CITATION: TECH COLOPROCTOL (2013); 17:207¿211. DOI: 10.1007/S10151-012-0906-6. THE AIM OF THIS STUDY IS TO PRESENT THE RESULTS OF THE ITALIAN SOCIETY OF COLORECTAL SURGERY [OR SOCIETA` ITALIANA DI CHIRURGIA COLORETTALE (SICCR)] LOGBOOK OF ADVERSE EVENT (AE) OCCURRING IN RELATION TO EMERGING TECHNOLOGIES IN COLOPROCTOLOGY (ETCS), OVER A 3-YEAR PERIOD. A TOTAL OF 245 PATIENTS (155 MALE AND 90 FEMALE; AGE RANGE: 20-75 YEARS) WITH AE WERE REPORTED. THE ¿¿OBSERVATIONS¿¿ ORIGINATED FROM THE SAME INSTITUTION OF THE AES IN 44 CASES, WHILE 201 PATIENTS HAD BEEN OPERATED ON SOMEWHERE ELSE. THE THREE MOST REPORTED EMERGING TECHNOLOGIES IN COLOPROCTOLOGY (ETC) ACCOUNTED FOR 227 OBSERVATIONS: PROCEDURE FOR PROLAPSED HAEMORRHOIDS (PPH [ETHICON]; N = 120; 61 MALE AND 59 FEMALE), STAPLED TRANSANAL RECTAL RESECTION (STARR) & STARR WITH CONTOUR TRANSTAR (ETHICON; N = 96; 12 MALE AND 84 FEMALE), AND TRANSANAL HAEMORRHOIDAL DE

  Patient problems: Blood Loss; Fistula; Incontinence; Obstruction/Occlusion; Pain; Sepsis

  MAUDE report 8704169 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: THE LAPAROSCOPIC-ASSISTED TRANSANAL RESECTION OF THE EXTERNAL PRIMARY AND RECURRENT RECTUM PROLAPSE USING THE STAPLER SYSTEM. AUTHOR : TOM G. KIRCHNER, OMID ABRI. CITATION: COLOPROCTOLOGY 2008;30:11¿5; DOI 10.1007/S00053-008-8002-5. THIS STUDY AIMED TO PRESENT THE NEWLY DEVELOPED CONTOUR TRANSTAR SYSTEM FOR S.T.A.R.R. FOR ITS HIGHEST POSSIBLE SAFETY TO PATIENT AND TO RULE OUT ANY POSSIBLE ENTEROCELE OR ADHESIONS IN THE LESSER PELVIS OR TO RELEASE THE SAME. A TOTAL OF 8 PATIENTS (AVERAGE AGE OF 76 YEARS) WITH AN EXTERNAL PRIMARY AND RECURRENT RECTUM PROLAPSE UNDERWENT A LAPAROSCOPIC-ASSISTED WITH CONTOUR TRANSTAR SYSTEM FOR S.T.A.R.R. IN THE PROCEDURE, AFTER PLACING ALL RADIAL (TOTAL OF SIX) SEAMS WITH VICRYL® 2 × 0 AND AFTER PLACING THE SO-CALLED LOOP SEAM WITH PROLENE® 2 × 0, THE PROLAPSE WAS OPENED WITH A CONVENTIONAL LINEAR CUTTER AT 03:00 LITHOTOMY POSITION AND OPENED ADDITIONALLY WITH A BLUE 60 CLIP AND 30 CLIP UP TO ITS BASE. THE ENTIRE PROLAPSE WAS THEN RESECTION IN A TYPICAL FASHION WITH THE SUPPLIED TRANSTAR¿-SET AND FOUR TO SIX CLIPS ON AN AVERAGE. COMPLICATIONS INCLUDED ARTERIAL BLEEDING IN THE BRACKET SEAM AREA (N=1) REQUIRING RE

  Patient problems: No Code Available

  MAUDE report 8703966 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: PERINEAL STAPLED RECTAL PROLAPSE RESECTION IN ELDERLY PATIENTS: LONG-TERM FOLLOW-UP. AUTHOR: EDWARD RAM, M.D. ¿ AVIAD HOFFMAN, M.D. ¿ YURI GOLDES, M.D. ¿ DANNY ROSIN, M.D. NIR HORESH, M.D. ¿ MORDECHAI GUTMAN, M.D. ¿ YAIR EDDEN, M.D. CITATION: DISEASES OF THE COLON & RECTUM (2018); 61:1316¿1319. DOI: 10.1097/DCR.0000000000001215. THE AIM OF THIS STUDY WAS TO ASSESS THE LONG-TERM RESULTS OF PERINEAL STAPLED PROLAPSE RESECTION (PSPR), FOCUSING ON MORBIDITY, RECURRENCE RATE, AND FUNCTIONAL OUTCOME. BETWEEN JANUARY 2010 TO JUNE 2013, 30 PATIENTS (2 MALE AND 28 FEMALE; AGE RANGE: 67-96 YEARS) WITH FULL-THICKNESS RECTAL PROLAPSE AND DAILY FECAL INCONTINENCE (FI) THAT WERE NOT SUITABLE FOR ABDOMINAL OR EXTENDED SURGERY THAT UNDERWENT PERINEAL STAPLED RECTAL RESECTION WERE INCLUDED IN THIS STUDY. THE OPERATION COMMENCES WITH RECTAL PROLAPSE EXTRACTION FOLLOWED BY LATERAL DIVISION OF THE PROLAPSE AT THE 3 O¿CLOCK POSITION BY USING A LINEAR STAPLER TLC75 (ETHICON) SO THAT THE STAPLER LINE ENDS 2 CM ABOVE THE DENTATE LINE. CONTOUR TRANSTAR STAPLER (ETHICON) IS INSERTED INTO THE PROLAPSED RECTUM AND TURNED IN A COUNTERCLOCKWISE FASHION OVER THE PROLAPSE

  Patient problems: Incontinence; No Code Available

  MAUDE report 8655439 ↗
• InjuryAug 3, 2018Break

  IT WAS REPORTED VIA LITERATURE ENTITLED: FUNCTIONAL OUTCOME AND QUALITY OF LIFE AFTER STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION SYNDROME. AUTHOR : KATJA WOLFF, M.D. ¿ LUKAS MARTI, M.D. ¿ ULRICH BEUTNER, PH.D. THOMAS STEFFEN, M.D. ¿ JOCHEN LANGE, M.D. ¿ FRANC H. HETZER, M.D. CITATION: DIS COLON RECTUM 2010; 53: 881¿888; DOI: 10.1007/DCR.0B013E3181CDB445. THE STUDY AIMED TO DETERMINE FUNCTIONAL OUTCOME AND QUALITY OF LIFE AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR OBSTRUCTED DEFECATION SYNDROME (ODS). BETWEEN JAN2007 AND NOV2008, 52 FEMALE PATIENTS (MEDIAN AGE OF 64 YEARS [20-87 YEARS]) WITH ODS UNDERWENT TRANSTAR PROCEDURE. CONTOUR TRANSTAR-STR5G STAPLER WAS USED TO COMPLETE THE TRANSTAR PROCEDURE. INTRAOPERATIVE COMPLICATIONS INCLUDED ONE PATIENT WHO HAD STAPLE LINE DEHISCENCE FIXED WITH ADDITIONAL SUTURES AND RECOVERED WITHOUT ANY SEQUALAE. AT POSTOPERATIVE 5 WEEKS, ONE PATIENT DEVELOPED PERIANAL VENOUS THROMBOSIS WHICH REQUIRED INCISION UNDER LOCAL ANESTHESIA. AT 6-WEEK FOLLOW-UP, 2 PATIENTS HAD SELF-LIMITING RECTAL BLEEDING FOR WHICH ONE PATIENT PERSISTED UNTIL THE 3 MONTH FOLLOW-UP. ADDITIONALLY, 2 PATIENTS HAD PERSISTING PAIN CAUSED BY 2 RESIDUAL S

  Patient problems: Blood Loss; Pain; Thrombosis; Wound Dehiscence

  MAUDE report 7748033 ↗
• InjuryAug 3, 2018Misfire

  IT WAS REPORTED VIA LITERATURE ENTITLED: SURGERY FOR OBSTRUCTED DEFAECATION: DOES THE USE OF THE CONTOUR DEVICE (TRANS-STARR) IMPROVE RESULTS? AUTHORS: H. WADHAWAN, A. J. SHORTHOUSE, S. R. BROWN CITATION: COLORECTAL DISEASE. 2010; 12: 885¿890. DOI: 10.1111/J.1463-1318.2009.01876.X THE OBJECTIVE OF THE STUDY WAS TO ASSESS SAFETY, EFFICACY, AND OUTCOMES OF STAPLED TRANSANAL RECTAL RESECTION (STARR) PROCEDURE FOR OBSTRUCTED DEFAECATION SYNDROME (ODS) WITH 2 STAPLING DEVICES, PPH01 AND TRANS-STARR. THIS PROCEDURE IS CARRIED OUT USING TWO CONVENTIONAL CIRCULAR STAPLER DEVICES (PPH01 AND CONTOUR TRANS-STARR [ETHICON]), SEQUENTIALLY, ANTERIORLY, AND POSTERIORLY TO COMPLETE A CIRCUMFERENTIAL RECTAL RESECTION. RECENTLY, THE CONTOUR TRANS-STARR DEVICE HAS BEEN INTRODUCED AS A MODIFICATION OF THE STARR PROCEDURE. A TOTAL OF 25 CONSECUTIVE PATIENTS WERE TREATED WITH STARR PPH01 CIRCULAR STAPLER (1 MALE AND 24 FEMALE PATIENTS; AGE: 55.59 YEARS; BMI: 26.97) AND 27 PATIENTS WERE TREATED WITH CONTOUR TRANS STARR CIRCULAR STAPLER (1 MALE AND 26 FEMALE PATIENTS; AGE: 56.11 YEARS; BMI: 25.98). DURING THE STARR PROCEDURE, THE OPEN PPH01 CIRCULAR STAPLER WAS INTRODUCED, WITH THE HEAD BEYOND THE SUTURE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7747936 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: MEDIASTINAL AND RETRO-/INTRAPERITONEAL EMPHYSEMA AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR-OPERATION) USING THE CONTOUR TRANSTAR STAPLER IN OBSTRUCTIVE DEFECATION SYNDROME. AUTHOR: TOBIAS SCHULTE, FRANK BOKELMANN, JOHANNES JONGEN, HANS-GUNTER PELEIKIS, FRED FANDRICH, VOLKER KAHLKE. CITATION: INT J COLORECTAL DIS (2008) 23:1019¿1020, DOI 10.1007/S00384-008-0516-Y; PUBLISHED ONLINE: 2 JULY 2008. THIS CASE SHOWS THE HISTORY OF A PATIENT WHO DEVELOPED A RETRO-/INTRAPERITONEAL AND MEDIASTINAL EMPHYSEMA FOLLOWING ¿TRANSTAR-OPERATION¿. A (B)(6)-YEAR-OLD WOMAN WAS TRANSFERRED TO THE MEDICAL EMERGENCY ROOM BY THE SURGEON IN CHARGE WITH DYSPNEA AND PAIN IN THE NECK. THE PAST MEDICAL AND SURGICAL HISTORY ONLY SHOWED A MEDICAL CONSULTATION BECAUSE OF A RECTOCELE WITH DEFECATION PROBLEMS. THE DAY BEFORE, A STARR-OPERATION USING THE CONTOUR TRANSTAR CURVED CUTTER STAPLER® WAS PERFORMED IN GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION. DURING THE CLINICAL EXAMINATION SHE SHOWED AN EMPHYSEMA OF THE NECK. THE CHEST X-RAY SHOWED A MEDIASTINAL AND NECK EMPHYSEMA. SUBSEQUENT A FLEXIBLE RECTOSCOPIES WAS PERFORMED WHICH SHOWED BESIDE SMALL AMOUNTS OF BLO

  Patient problems: Dyspnea; Pain; Pulmonary Emphysema

  MAUDE report 7743912 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: MIDTERM RESULTS AFTER PERINEAL STAPLED PROLAPSE RESECTION FOR EXTERNAL RECTAL PROLAPSE. AUTHOR: DIANA SEHMER, MD; LUKAS MARTI, MD; KATJA WOLFF, MD; FRANC H. HETZER, MD. CITATION: DIS COLON RECTUM 2013; 56: 91¿96, DOI: 10.1097/DCR.0B013E31826CBBEA. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE MIDTERM RECURRENCE RATES AFTER PERINEAL STAPLED PROLAPSE RESECTION (PSP). SECONDARY AIMS WERE TO REPORT THE MIDTERM FUNCTIONAL RESULTS AND PATIENT SATISFACTION AFTER PSP. BETWEEN THE PERIODS OF NOVEMBER 2007 TO OCTOBER 2011, A TOTAL OF 56 PATIENTS (2 MEN, 3.6%) WITH EXTERNAL RECTAL PROLAPSE WERE TREATED BY THE USE OF THE PSP PROCEDURE. NOTABLY, 32 PATIENTS THAT WERE PART OF THE 2010 STUDY WERE ALSO INCLUDED IN THIS ANALYSIS. DURING THE PROCEDURES, THE PROLAPSE WAS CUT OPEN AT THE 3 O'CLOCK POSITION WITH THE USE OF A HORIZONTAL STAPLER SUCH AS THE PROXIMATE 75-MM LINEAR CUTTER STAPLER (GIA STAPLER; TLC75; ETHICON ENDO-SURGERY, CINCINNATI, OH). AFTER OPENING THE PROLAPSE, AN ORIENTATION SUTURE WAS PLACED AT THE END OF THE STAPLE LINE. THE CONTOUR STAPLER (STR5G; ETHICON ENDO-SURGERY, CINCINNATI, OH) WAS INSERTED INTO THE PROLAPSE, AND THE PROLAPSE

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Peritonitis; Urinary Retention

  MAUDE report 7743747 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: LONG-TERM RESULTS FOLLOWING TRANSANAL RECTAL RESECTION IN PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME AUTHOR: R. PROSST. CITATION: COLOPROCTOLOGY 2014 36:54¿55, DOI 10.1007/S00053-013-0428-3; PUBLISHED ONLINE: 15/01/2014. THE GOAL OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE FUNCTIONAL LONG-TERM RESULTS AND QUALITY OF LIFE FOLLOWING TRANSTAR PROCEDURE SURGERY. THE 77 CONSECUTIVE PATIENTS (68 FEMALE) WITH OBSTRUCTED DEFECATION SYNDROME AVERAGED 65 YEARS OF AGE (20-90 YRS.) WERE INCLUDED IN THE STUDY. THE TRANSTAR OPERATIONS OCCURRED BETWEEN JANUARY 2007 AND MARCH 2010. CONTOUR TRANSTAR PROCEDURE ALLOWS ACHIEVEMENT OF A SIGNIFICANTLY LARGER RESECTION THAN THE STARR PROCEDURE, DUE TO BETTER INTRA-OPERATIVE VIEW AND MONITORING. HOWEVER, THIS DID NOT RESULT IN ANY VERIFIABLE CLINICALLY FUNCTIONAL IMPROVEMENT, AT LEAST WITHIN A BRIEF FOLLOW-UP OBSERVATION PERIOD. NINE PATIENTS REPORTED NEWLY OCCURRING POST-OPERATIVE INCONTINENCE FOR WHICH ADDITIONAL TREATMENT WAS REQUIRED. THIS VERIFIES THAT THE INCONTINENCE FREQUENTLY ASSOCIATED WITH A RECTAL PROLAPSE SHOULD NOT BE VIEWED AS A SURGICAL CONTRAINDICATION BUT CONTINENT PATIENTS SHOULD BE NOTI

  Patient problems: Incontinence; No Code Available

  MAUDE report 7742621 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: STARR WITH PPH-01 AND CCS30 CONTOUR TRANSTAR FOR OBSTRUCTED DEFECATION SYNDROME AUTHOR: SILVIA SAVASTANO, MD; GIUSEPPE VALENTI, MD; FRANCESCO CAVALLIN, MS AND CLAUDIO MISSAGLIA, MD. CITATION: SURGICAL INNOVATION 19(2) 171¿174; 2012, DOI: 10.1177/1553350611425504. THE AIM OF THIS COMPARATIVE PROSPECTIVE STUDY WAS TO COMPARE STARR WHICH USED CIRCULAR PPH-01 STAPLERS (ETHICON ENDO-SURGERY; CINCINNATI, OH) AND TRANSTART WHICH USED CONTOUR TRANSTAR CCS30 IN PATIENTS WITH OBSTRUCTIVE DEFECATION SYNDROME (ODS). BETWEEN JANUARY 2007 AND JUNE 2009, 64 FEMALE PATIENTS UNDERWENT STARR FOR ODS (32 STARR, AGE RANGE: 54.1 ± 12.7 AND 32 TRANSTAR, AGE RANGE: 60.5 ± 11.4). NO INTRAOPERATIVE COMPLICATIONS APPEARED IN THE STARR GROUP; HOWEVER, 2 POSTERIOR FLOOR PARTIAL DEHISCENCES OF THE SUTURE OCCURRED IN THE TRANSTAR GROUP AND WERE SOLVED WITH MANUAL INTRAOPERATIVE SUTURE WITH NO CONSEQUENCES IN THE POSTOPERATIVE PERIOD. WITH REGARD TO EARLY COMPLICATIONS, RECTAL BLEEDING WAS REPORTED IN 4 CASES IN THE STARR GROUP: 2 WITHIN 24 HOURS, 1 WITHIN 36 HOURS, AND 1 WITHIN 48 HOURS OF THE OPERATION, ALL OF WHICH WERE SOLVED WITH SURGICAL REVISION. IN THE TRANSTAR GR

  Patient problems: Blood Loss; Granuloma; Incontinence; No Code Available; Wound Dehiscence

  MAUDE report 7742190 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: FUNCTIONAL OUTCOMES AFTER DISC EXCISION IN DEEP ENDOMETRIOSIS OF THE RECTUM USING TRANSANAL STAPLERS A SERIES OF 111 CONSECUTIVE PATIENTS. AUTHOR: HORACE ROMAN, M.D., PH.D.,A,B BASMA DARWISH, M.D.,A VAL_ERIE BRIDOUX, M.D., PH.D.,C RACHID CHATI, M.D.,C SABRINA KERMICHE, M.D.,C JULIEN COGET, M.D.,C EMMANUEL HUET, M.D.,C AND JEAN-JACQUES TUECH, M.D., PH.D. CITATION: FERTIL STERIL 2017;107:977¿86; DOI: HTTP://DX.DOI.ORG/10.1016/J.FERTNSTERT.2016.12.030. THIS PROSPECTIVE STUDY AIMED TO ASSESS THE POSTOPERATIVE OUTCOMES OF PATIENTS WITH RECTAL ENDOMETRIOSIS MANAGED BY DISC EXCISION USING TRANSANAL STAPLERS. BETWEEN JUN 2009 AND JUN 2016, 11 FEMALE PATIENTS WITH DEEP ENDOMETRIOSIS OF THE RECTUM UNDERWENT DISC EXCISION USING TWO DIFFERENT TRANSANAL STAPLERS: CONTOUR TRANSTAR STAPLER ¿ ROUEN TECHNIQUE (N=42; MEAN AGE SD OF 29.8±4.2 YEARS) AND END-TO-END ANASTOMOSIS CIRCULAR TRANSANAL STAPLER (N=69; MEAN AGE SD OF 29.6±4.5 YEARS). IN PATIENTS WHO UTILIZED CONTOUR TRANSTAR STAPLER, POSTOPERATIVE COMPLICATIONS INCLUDED RECTOVAGINAL FISTULA (N=5) PELVIC ABSCESS (N=4) REQUIRING SECOND LAPAROSCOPY (N=2) AND CASES ONLY MANAGED BY ANTIBIOTICS (N=2),

  Patient problems: Abscess; Fistula; No Code Available

  MAUDE report 7740592 ↗