N/A CDH21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 10705036003441), received between Jan 15, 2018 and Sep 24, 2026 — classified as 8 deaths, 101 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (44 reports).

13 other recalls cover devices cleared under the same FDA submission (K983536); they may or may not involve this specific model.

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 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Failure to Form Staple

  It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883389 ↗
• InjuryAug 13, 2026Patient Device Interaction Problem

  It was reported via Journal Article: Title: Endoscopy vs esophagram for routine anastomotic evaluation following McKeown esophagectomy: a retrospective cohort study Author's: Sheng H., Yan H., Caiyan F., Zhichao L., Jiadi W., Daofeng W., Binyang X., Jiyang C., Huilin S., Xiaobin C., Bin L., Qianwen L., Weidong W., Hong Y.Citation: International Journal of Surgery. 2026.DOI: 10.1097/JS9.0000000000005547.The aim of this study is to report the enrolled 246 patients with esophageal cancer who underwent McKeown esophagectomy at Sun Yat-sen University Cancer Center between 2022 and 2023. 107 patients who underwent routine ES for anastomotic evaluation were included in the ES group, while 139 patients. Circular stapler (EES) was used in an end-to-side esophagogastric anastomosis, and Vicryl Plus (ETH) was used in anastomosis in inverted and reinforced with full-thickness interrupted.Reported Complications:CDH21A/CDH25A circular staple (EES)Vicryl Plus (ETH)ES Group (n=107).Anastomotic leakage (AL) (n=8)Treatment: not reported.EP Group (n=139) Anastomotic leakage (AL) (n=17)Treatment: not reported.In conclusion, ES might be superior to EP for the routine evaluation of anastomosis after Mc

  Patient problems: Failure to Anastomose

  MAUDE report 50233983 ↗
• MalfunctionApr 10, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED AND OOZING OCCURRED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840968 ↗
• MalfunctionJan 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNK PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961445 ↗
• MalfunctionJan 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE COMBINED PANCREATICODUODENECTOMY SURGERY, COULD NOT FIRE. CHANGED TO THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958122 ↗
• MalfunctionNov 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ESOPHAGUS SURGERY COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477996 ↗
• MalfunctionOct 17, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322561 ↗
• MalfunctionOct 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23192532 ↗
• MalfunctionAug 14, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN OPEN TOTAL GASTRECTOMY, ESOPHAGOJEJUNOSTOMY WAS PERFORMED. CDH21A WAS USED AT THE FIRST TIME. A LEAK WAS FOUND AT THE LEAK TEST, SO THE ANASTOMOSIS SITE WAS RESECTED, AND A PURSE-STRING FORCEPS WAS PLACED ON THE ESOPHAGUS SIDE AND PURSE-STRING WAS PERFORMED. CDH25P WAS USED AT THE SECOND TIME. THE CDH25P WAS INSERTED FROM THE INSERTION PORT USED THE FIRST TIME, AND THE ANASTOMOSIS WAS PERFORMED AGAIN, BUT WHEN IT WAS REMOVED, THERE WAS STAPLED ON THE JEJUNUM SIDE ONLY. THE ANASTOMOSIS WAS NOT COMPLETED, AND THE DEVICE COULD BE REMOVED WITHOUT LOOSE THE ANVIL. APPARENTLY, ONLY ONE DONUT FORMED ON THE ANVIL SIDE (ESOPHAGUS SIDE). EVENTUALLY, A HAND-SEWN RECONSTRUCTION WAS PERFORMED, AND THE CASE WAS COMPLETED. THE PATIENT PASSED AWAY AFTER THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 22803617 ↗
• MalfunctionAug 11, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A PROCTRECTOMY SURGERY, NOTED ANVIL FELL OFF. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770873 ↗
• MalfunctionJun 26, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336325 ↗
• MalfunctionJun 10, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ESOPHAGEAL SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175306 ↗
• MalfunctionJun 9, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A MISC; ESOPHAGUS SURGERYSURGERY, THE DEVICE COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167529 ↗
• MalfunctionApr 22, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT, BUT THERE WERE SOME STAPLES DEPLOYED ON THE TISSUE, THEN CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881598 ↗
• InjuryMar 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPARISON OF THE SUBTOTAL AND NARROW GASTRIC CONDUIT FOR CERVICAL ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY IN ESOPHAGEAL CANCER PATIENTS: A PROPENSITY SCORE-MATCHED ANALYSIS. AUTHOR: KEN SASAKI 1 G, YUSUKE TSURUDA 1, MASATAKA SHIMONOSONO1, MASAHIRO NODA 1, YASUTO UCHIKADO1 - LTARU OMOTO1, TETSURO SETOYAMA 1, DAISUKE MATSUSHITA 1, TAKAAKI ARIGAMI 1, KENJI BABA 1, HIROSHI KURA HARA 1, TAKAO OHTSUKA. CITATION: HTTPS:/ /DOI.ORG/ 10. 1007 /S 10388-023-01027-7. A RETROSPECTIVE STUDY THE AIM IS TO DETERMINE THE OPTIMAL GASTRIC CONDUIT TYPE INVESTIGATED AND COMPARED THE POSTOPERATIVE COMPLICATIONS BETWEEN NGC AND SGC USED IN CERVICAL CIRCULAR-TAPERED ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY THROUGH A PROPENSITY SCORE-MATCHED ANALYSIS. BETWEEN 2008 AND 2022, 577 CONSECUTIVE ESOPHAGEAL CANCER PATIENTS WHO UNDERWENT ESOPHAGECTOMY AND CERVICAL CIRCULAR-STAPLED ESOPHAGOGASTROSTOMY WERE ENROLLED IN THIS STUDY. RESULTS OF THE 577 PATIENTS, 77 WERE INCLUDED EACH IN THE SGC AND NGC CLINICAL CHARACTERISTICS DID NOT DIFFER BETWEEN THE TWO GROUPS. THE ANASTOMOTIC LEAKAGE RATE WAS SIGNIFICANTLY LOWER IN THE SGC GROUP THAN IN THE NGC GROUP (5%). THERE WERE (N=4

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 21631566 ↗
• InjuryMar 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: TEXTBOOK OUTCOME AFTER GASTRECTOMY FOR GASTRIC CANCER IS ASSOCIATED WITH IMPROVED OVERALL AND DISEASE-FREE SURVIVAL. AUTHORS: CANDAN CETINKAYA-HOSGÖR, PHILIPPA SEIKA, JONAS RAAKOW, DINO KRÖLL I ID EVA MARIA DOBRINDT, MAX MAGNUS MAURER, FRIEDERIKE MARTIN, RAMIN RAUL OSSAMI SAIDY, PETER THUSS-PATIENCE, JOHANN PRATSCHKE, MATTHIAS BIEBL, AND CHRISTIAN DENECKE. CITATION: JOURNAL CLINICAL MEDICINE. 2023 HTTPS://DOI.ORG/10.3390/. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE EFFECT OF THE SURGICAL OUTCOME ON SURVIVAL AND TO IDENTIFY PATIENT- AND PROCEDURE-RELATED FACTORS THAT PREDICT THE ACHIEVEMENT OF TEXTBOOK OUTCOME (TO) IN GASTRIC CANCER SURGERY AT THE INSTITUTION AND TO ASSESS THE IMPACT OF ACHIEVING TO ON OVERALL SURVIVAL (OS) AND DISEASE-FREE SURVIVAL (DFS). BETWEEN JANUARY 2017 AND DECEMBER 2021, A TOTAL OF 99 PATIENTS WERE INCLUDED IN THIS STUDY. THE PATIENTS UNDERWENT EITHER TOTAL GASTRECTOMY, SUBTOTAL GASTRECTOMY, OR TRANS-HIATAL EXTENDED GASTRECTOMY FOR GASTRIC CANCER, ALL WITH CURATIVE INTENT. SOME SURGERIES WERE PERFORMED OPEN AND OTHERS LAPAROSCOPIC. CIRCULAR ANASTOMOSIS WAS PERFORMED UTILIZING EITHER AN ECHELON CIRCULARTM POWERED

  Patient problems: Insufficient Information; Pain; Unspecified Infection

  MAUDE report 21606211 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPARISON OF THE SUBTOTAL AND NARROW GASTRIC CONDUIT FOR CERVICAL ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY IN ESOPHAGEAL CANCER PATIENTS: A PROPENSITY SCORE-MATCHED ANALYSIS AUTHOR: KEN SASAKI 1 G, YUSUKE TSURUDA 1, MASATAKA SHIMONOSONO1, MASAHIRO NODA 1, YASUTO UCHIKADO1 - LTARU OMOTO1, TETSURO SETOYAMA 1, DAISUKE MATSUSHITA 1, TAKAAKI ARIGAMI 1, KENJI BABA 1, HIROSHI KURA HARA 1, TAKAO OHTSUKA CITATION: HTTPS:/ /DOI.ORG/ 10. 1007 /S 10388-023-01027-7. A RETROSPECTIVE STUDY THE AIM IS TO DETERMINE THE OPTIMAL GASTRIC CONDUIT TYPE INVESTIGATED AND COMPARED THE POSTOPERATIVE COMPLICATIONS BETWEEN NGC AND SGC USED IN CERVICAL CIRCULAR-TAPERED ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY THROUGH A PROPENSITY SCORE-MATCHED ANALYSIS. BETWEEN 2008 AND 2022, 577 CONSECUTIVE ESOPHAGEAL CANCER PATIENTS WHO UNDERWENT ESOPHAGECTOMY AND CERVICAL CIRCULAR-STAPLED ESOPHAGOGASTROSTOMY WERE ENROLLED IN THIS STUDY. RESULTS OF THE 577 PATIENTS, 77 WERE INCLUDED EACH IN THE SGC AND NGC CLINICAL CHARACTERISTICS DID NOT DIFFER BETWEEN THE TWO GROUPS. THE ANASTOMOTIC LEAKAGE RATE WAS SIGNIFICANTLY LOWER IN THE SGC GROUP THAN IN THE NGC GROUP (5%) THERE WERE (N=499)

  Patient problems: Failure to Anastomose

  MAUDE report 21582933 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: EXFOLIATE CANCER CELL ANALYSIS IN RECTAL CANCER SURGERY: COMPARISON OF LAPAROSCOPIC AND TRANSANAL TOTAL MESORECTAL EXCISION, A PILOT STUDY AUTHORS: KIHO YOU, JUNG-AH HWANG, DAE KYUNG SOHN, DONG WOON LEE, SUNG SIL PARK, KYUNG SU HAN, CHANG WON HONG, BUN KIM, BYUNG CHANG KIM, SUNG CHAN PARK, JAE HWAN OH CITATION: ANN COLOPROCTOL; HTTPS://DOI.ORG/ 10.3393/AC.2023.004 79.0068. THE AIM OF THIS STUDY WAS TO ANALYZE SAMPLES OBTAINED THROUGH LAVAGE TO COMPARE LAPAROSCOPIC TOTAL MESORECTAL EXCISION (LAPTME) AND TRANSANAL TME (TATME). BETWEEN JUNE 2020 AND JANUARY 2021, A TOTAL OF 20 PATIENTS WHO WERE DIAGNOSED WITH ADENOCARCINOMA OF RECTAL CANCER WERE INCLUDED IN THE STUDY. AMONG THESE, 13 PATIENTS (5 WERE MALES; MEAN AGE WAS 59.0 (54.0-64.0) YEARS) UNDERWENT LAPTME AND 7 PATIENTS (5 WERE MALES; MEAN AGE WAS 63.0 (53.5-67.0) YEARS) UNDERWENT TATME. UPON TME AND DISTAL RESECTION COMPLETION, PROXIMAL RESECTION WAS PERFORMED USING AN EXTRACORPOREAL METHOD, FOLLOWED BY COLORECTAL OR COLOANAL ANASTOMOSIS. COLORECTAL ANASTOMOSIS WAS PERFORMED USING A CIRCULAR STAPLER (25-29 MM; CDH, ETHICON). ALL PATIENTS WERE FOLLOWED UP FOR AN AVERAGE OF 32.5 MONTHS (

  Patient problems: Abscess; Failure to Anastomose

  MAUDE report 21582545 ↗
• InjuryMar 11, 2025Adverse 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: USEFULNESS OF A POWERED CIRCULAR STAPLER COMPARED WITH A MANUAL CIRCULAR STAPLER IN PATIENTS UNDERGOING COLORECTAL CANCER SURGERY: A RETROSPECTIVE COHORT STUDY AND SYSTEMATIC REVIEW AUTHOR: RIE MIZUMOT01,2 , NORIKATSU MIYOSHI1 ¿ 2, RIE HAYASHI1 , SHINYA KATO1 , SOICHIRO MINAMI1 , MITSUNOBU TAKEDA 1 , YUKI SEKIDO1 , TSUYOSHI HATA 1 , ATSUSHI HAMABE1 , TAKAYUKI OGINO1 , MITSUYOSHITEI3 , YOSHINORIKAGAWA4 , MAMORUUEMURA1 , YUICHIRODOKI1 AND HIDETOSHIEGUCHI1 CITATION: DOI: 10.3892/OL.2024.14640. THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY. PATIENTS UNDERGOING RADICAL RESECTION AND ANASTOMOSIS FOR SIGMOID COLON OR RECTAL CANCER USING A CIRCULAR STAPLER. BETWEEN JANUARY 2018 AND DECEMBER 2022 WAS CONDUCTED, THE STUDY INCLUDED 414 PATIENTS:(N= 231)IN THE MANUAL CIRCULAR STAPLER GROUP AND (N=183) IN THE POWERED CIRCULAR STAPLER (PCS) GROUP .AN INCREASED RISK RATIO WAS OBSERVED IN THE MANUAL GROUP COMPARED WITH THE AUTOMATIC GROUP WHEN RESTRICTED TO ELDERLY PATIENTS. SIMILARLY, A META-ANALYSIS FOUND A SIGNIFICANTLY HIGHER ANASTOMOTIC COMPLICATION RISK IN THE MANUAL GROUP COMPARED WITH THE AUTOMATIC GROUP PATIENTS IN THE PCS GROUP WERE SIGNIFICANTL

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

  MAUDE report 21577049 ↗
• InjuryMar 11, 2025Adverse 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: TEXTBOOK OUTCOME AFTER GASTRECTOMY FOR GASTRIC CANCER IS ASSOCIATED WITH IMPROVED OVERALL AND DISEASE-FREE SURVIVAL. AUTHORS: CANDAN CETINKAYA-HOSGÖR, PHILIPPA SEIKA, JONAS RAAKOW, DINO KRÖLL I ID EVA MARIA DOBRINDT, MAX MAGNUS MAURER, FRIEDERIKE MARTIN, RAMIN RAUL OSSAMI SAIDY, PETER THUSS-PATIENCE, JOHANN PRATSCHKE, MATTHIAS BIEBL, AND CHRISTIAN DENECKE CITATION: JOURNAL CLINICAL MEDICINE. 2023 HTTPS://DOI.ORG/10.3390/. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE EFFECT OF THE SURGICAL OUTCOME ON SURVIVAL AND TO IDENTIFY PATIENT- AND PROCEDURE-RELATED FACTORS THAT PREDICT THE ACHIEVEMENT OF TEXTBOOK OUTCOME (TO) IN GASTRIC CANCER SURGERY AT THE INSTITUTION AND TO ASSESS THE IMPACT OF ACHIEVING TO ON OVERALL SURVIVAL (OS) AND DISEASE-FREE SURVIVAL (DFS). BETWEEN JANUARY 2017 AND DECEMBER 2021, A TOTAL OF 99 PATIENTS WERE INCLUDED IN THIS STUDY. THE PATIENTS UNDERWENT EITHER TOTAL GASTRECTOMY, SUBTOTAL GASTRECTOMY, OR TRANS-HIATAL EXTENDED GASTRECTOMY FOR GASTRIC CANCER, ALL WITH CURATIVE INTENT. SOME SURGERIES WERE PERFORMED OPEN AND OTHERS LAPAROSCOPIC. CIRCULAR ANASTOMOSIS WAS PERFORMED UTILIZING EITHER AN ECHELON CIRCULARTM POWERED S

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21574693 ↗
• InjuryMar 4, 2025Adverse 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: INCIDENCE OF ANASTOMOTIC LEAKAGE USING POWERED CIRCULAR STAPLERS VERSUS MANUAL CIRCULAR STAPLERS FOR LEFT COLORECTAL ANASTOMOSIS: A COST-EFECTIVENESS ANALYSIS. AUTHORS : V. PLA-MARTÍ, J. MARTÍN-ARÉVALO, D. MORO-VALDEZATE, S. GARCÍA-BOTELLO, L. PÉREZ-SANTIAGO, I. BARRACHINA-MARTINEZ, S. GONZÁLEZ-DE-JULIÁN, D. VIVAS-CONSUELO, A. ESPÍ-MACÍAS CITATIONS: TECHNIQUES IN COLOPROCTOLOGY (2024) 28:76. HTTPS://DOI.ORG/10.1007/S10151-024-02936-0. THE AIM OF THIS STUDY WAS TO ASSESS IF THE USE OF A NEW POWERED CIRCULAR STAPLER IS COST-EFFECTIVE. THIS OBSERVATIONAL STUDY INCLUDED PATIENTS UNDERGOING LEFT-SIDED CIRCULAR STAPLED COLORECTAL ANASTOMOSIS BETWEEN JANUARY 2018 AND DECEMBER 2021. A TOTAL OF 330 PATIENTS WERE INCLUDED IN THE STUDY, 165 IN EACH GROUP. PATIENTS WERE CATEGORIZED INTO TWO GROUPS BASED ON WHETHER THE ANASTOMOSIS WAS PERFORMED USING MCS ( MANUAL CIRCULAR STAPLER ) OR ECPS ( ECHELON CIRCULAR¿ ETHICON, SOMERVILLE, NJ, USA ). THE REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKS ( N=8). IN CONCLUSION, THE INCREMENTAL COST OF POWERED CIRCULAR STAPLER COMPARED WITH MANUAL DEVICES WAS OFFSET BY THE SAVINGS FROM LOWERED INCIDENCE AND COST O

  Patient problems: Failure to Anastomose

  MAUDE report 21514415 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: EXFOLIATE CANCER CELL ANALYSIS IN RECTAL CANCER SURGERY: COMPARISON OF LAPAROSCOPIC AND TRANSANAL TOTAL MESORECTAL EXCISION, A PILOT STUDY. AUTHORS: KIHO YOU, JUNG-AH HWANG, DAE KYUNG SOHN, DONG WOON LEE, SUNG SIL PARK, KYUNG SU HAN, CHANG WON HONG, BUN KIM, BYUNG CHANG KIM, SUNG CHAN PARK, JAE HWAN OH CITATION: ANN COLOPROCTOL; HTTPS://DOI.ORG/ 10.3393/AC.2023.004 79.0068. THE AIM OF THIS STUDY WAS TO ANALYZE SAMPLES OBTAINED THROUGH LAVAGE TO COMPARE LAPAROSCOPIC TOTAL MESORECTAL EXCISION (LAPTME) AND TRANSANAL TME (TATME). BETWEEN JUNE 2020 AND JANUARY 2021, A TOTAL OF 20 PATIENTS WHO WERE DIAGNOSED WITH ADENOCARCINOMA OF RECTAL CANCER WERE INCLUDED IN THE STUDY. AMONG THESE, 13 PATIENTS (5 WERE MALES; MEAN AGE WAS 59.0 (54.0-64.0) YEARS) UNDERWENT LAPTME AND 7 PATIENTS (5 WERE MALES; MEAN AGE WAS 63.0 (53.5-67.0) YEARS) UNDERWENT TATME. UPON TME AND DISTAL RESECTION COMPLETION, PROXIMAL RESECTION WAS PERFORMED USING AN EXTRACORPOREAL METHOD, FOLLOWED BY COLORECTAL OR COLOANAL ANASTOMOSIS. COLORECTAL ANASTOMOSIS WAS PERFORMED USING A CIRCULAR STAPLER (25-29 MM; CDH, ETHICON). ALL PATIENTS WERE FOLLOWED UP FOR AN AVERAGE OF 32.5 MONTHS

  Patient problems: Failure to Anastomose

  MAUDE report 21504284 ↗
• InjuryMar 3, 2025Adverse 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: THE IMPACT OF POWERED CIRCULAR STAPLERS ON ANASTOMOTIC LEAK IN LEFT-SIDED COLORECTAL CANCER SURGERIES AUTHOR: HAYOUNG LEE, YONG SIK YOON, YOUNG IL KIM, EUN JUNG PARK, MIN HYUN KIM, JONG LYUL LEE, CHAN WOOK KIM, IN JA PARK & SEOK-BYUNG LIM WEB ADDRESS: THIS RETROSPECTIVE STUDY INCLUDED COLORECTAL CANCER PATIENTS AT THE TERTIARY REFERRAL CENTER FROM APRIL TO OCTOBER 2023 WHO UNDERWENT ANTERIOR OR LOW ANTERIOR RESECTION (LAR) USING A CIRCULAR STAPLER. ACCORDING TO ENERGY SOURCE, PATIENTS WERE DIVIDED INTO POWERED AND MANUAL GROUPS, WHICH USED TWO POWERED AND FOUR TYPES OF MANUAL STAPLERS, RESPECTIVELY. ALL OPEN, LAPAROSCOPIC, AND ROBOTIC APPROACHES WERE INCLUDED. PROPENSITY SCORE MATCHING (PSM) ANALYSIS WAS USED TO REDUCE SELECTION BIAS. THIS RETROSPECTIVE STUDY INCLUDED COLORECTAL CANCER PATIENTS AT THE TERTIARY REFERRAL CENTER FROM APRIL TO OCTOBER 2023 WHO UNDERWENT ANTERIOR OR LOW ANTERIOR RESECTION (LAR) USING A CIRCULAR STAPLER. ACCORDING TO ENERGY SOURCE, PATIENTS WERE DIVIDED INTO POWERED AND MANUAL GROUPS, WHICH USED TWO POWERED AND FOUR TYPES OF MANUAL STAPLERS, RESPECTIVELY. ALL OPEN, LAPAROSCOPIC, AND ROBOTIC APPROACHES WERE INCL

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

  MAUDE report 21504270 ↗
• InjuryFeb 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CSG-F541 STUDY SERIOUS ADVERSE EVENT (SAE): AS PART OF STUDY "A DIGITAL SURGICAL WORKFLOW AND DIGITAL DEVICE BRIEFING TOOL TO REDUCE MORBIDITY AND MORTALITY AFTER PRIMARY STAPLED COLORECTAL ANASTOMOSIS" THE FOLLOWING EVENT WAS REPORTED: SAE CAUSALITY ASSESSMENT, SURGICAL PROCEDURE PERFORMED: SIGMOIDECTOMY. SAE EVENT TERM FIRST POD, LEFT FOOT, COMPARTMENT SYNDROME LOWER LEG DESCRIPTION OF THE EVENT: FIRST POD, LEFT FOOT, COMPARTMENT SYNDROME, EMERGENCY FASCIOTOMY. IS THERE A REASONABLE POSSIBILITY OF RELATEDNESS TO PERFORMED SURGICAL PROCEDURE: YES RELATEDNESS TO SURGICAL EQUIPMENT USED: YES, PATIENT POSTPONING RELATEDNESS TO STUDY TEST PRODUCT: SPI DIGITAL SURGICAL WORKFLOW SOFTWARE/HARDWARE: NO RELATION TO STUDY TEST PRODUCT: DEVICE BRIEFING TOOL (DDBT CHECKLIST): NO SAE SERIOUSNESS CRITERIA IN- PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: PATIENT WAS HOSPITALIZED ON: (B)(6) 2025, PATIENT WAS DISCHARGED ON: NOT YET, MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATING ILLNESS OR INJURY OR PERMANENT TO A BODY STRUCTURE OR A BODY FUNCTION, SAE INTENSITY SEVERE, SAE START DATE ON (B)(6) 2025, SAE END DATE: ONGOING. ACTION TAKEN SURGICAL THERAPY/PROCEDURE

  Patient problems: Insufficient Information

  MAUDE report 21446381 ↗
• MalfunctionNov 13, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ILEOSTOMY CLOSURE WHILE TRYING TO USE THE GLC80, THE DEVICE WOULD NOT FIRE AND IT WOULD CLOSE TOGETHER. THEY ALSO SAID A PIN FELL OUT OF THE DEVICE. GRABBED ANOTHER DEVICE TO COMPLETE CASE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674039 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983536. One submission often covers many models, so check the product and lot details in each record.

• Z-1268-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1271-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1272-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1275-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1273-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1274-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1267-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1277-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1276-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1278-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1269-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1270-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-0672-2018 · Oct 23, 2017 · Terminated
  Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.