ENDOPOUCH RETRIEVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 456 adverse event reports that list this exact device (DI 10705036012986), received between Nov 30, 2017 and Sep 23, 2026 — classified as 19 injuries, 437 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (299 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 456 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Split, Cut or Torn

  It was reported that during a robotic cholecystectomy, a POUCH retrieval bag was used to extract the gallbladder. It was stated that the bag broke and a piece of the bag remained in the abdomen. The piece was retrieved from the patient and there were no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867357 ↗
• MalfunctionSep 22, 2026Material Split, Cut or Torn

  It was reported that in the middle of an Unknown surgery the Pouch broke inside the patient and it lacerated their liver.

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 50853668 ↗
• MalfunctionSep 21, 2026Material Split, Cut or Torn

  It was reported that during a Laparoscopic Appendectomy the string on the endo pouch bag broke off also while trying to get the specimen out. No harm came to the patient and they were able to remain laparoscopic.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840351 ↗
• MalfunctionAug 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234325 ↗
• MalfunctionAug 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234267 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209844 ↗
• MalfunctionAug 3, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121452 ↗
• MalfunctionJul 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY WHILE ATTEMPTING TO REMOVE THE SPECIMEN FROM INSIDE ABDOMEN, THE ENDO-POUCH BURST OPEN CAUSING THE CONTENT OF THE SUBTOTAL GALLBLADDER TO SPILL BACK INTO THE ABDOMINAL CAVITY. FURTHER CLEANING OF THE SPILLED CONTENTS WERE REQUIRED TO SOMEWHAT RECTIFY THE ISSUE. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733169 ↗
• MalfunctionJun 11, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, POUCH BREAKING DURING SURGERY. EACH TIME THE BAG SPLIT OPEN WHILE TRYING TO REMOVE IT FROM THE PATIENT AND THE SPECIMEN HAS FALLEN BACK INTO THE PATIENT. THERE HAVE BEEN NO ADVERSE PATIENT OUTCOMES REPORT DUE TO THESE EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25478119 ↗
• MalfunctionMay 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT THE POUCH BROKE DURING THE CASE. NO PATIENT HARM. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284769 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BAG NOT ATTACHED. DEFORMED METAL. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175072 ↗
• MalfunctionMay 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE THE SURGEON WAS RETRACTING OR REMOVING THE DEVICE, THE DEVICE FELL APART. ALL PIECES WERE ABLE TO BE RETRIEVED FROM INSIDE THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165626 ↗
• MalfunctionMay 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING UNK PROCEDURE, SPECIMEN REMOVAL, THE END OF THE POUCH TORE OR RIPPED DURING USE. A NEW SPECIMEN REMOVAL BAG WAS OPENED TO CONTINUE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165287 ↗
• MalfunctionMay 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, SURGEON WENT TO PLACE A LIPOMA IN THE POUCH WHEN THE POUCH RIPPED OFF THE METAL FRAME. HAD TO REMOVE THE POUCH AND USE ANOTHER ONE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119139 ↗
• MalfunctionApr 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, WHEN THE POUCH WAS OPENED IN THE ABDOMINAL CAVITY, THE LEFT FRAME WAS DETACHED AND THE POUCH DID NOT OPEN PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873468 ↗
• MalfunctionMar 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE WHEN STAFF WERE PLACING THE SPECIMEN INTO THE COLLECTION BAG, THE BAG TORE DURING THE REMOVAL PROCESS, RESULTING IN THE SPECIMEN NOT BEING FULLY SECURED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667076 ↗
• MalfunctionMar 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ROBOTIC WEDGE RESECTION PROCEDURE, THE DEVICE BROKE WHILE TRYING TO PULL THE SPECIMEN. THE BAG BROKE IN THE INCISION AND A PIECE OF THE BAG FELL IN THE CHEST CAVITY OF THE PATIENT, IT WAS THEN RETRIEVED BY THE SURGEON. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666599 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE 10 MM ENDOCATCH BAG BROKEN WHEN RETRIEVING IT. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484865 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RETRIEVAL BAGS BROKE AS SPECIMEN BEING REMOVED FROM ABDOMEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472121 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RETRIEVAL BAGS BROKE AS SPECIMEN BEING REMOVED FROM ABDOMEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472084 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RETRIEVAL BAGS BROKE AS SPECIMEN BEING REMOVED FROM ABDOMEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472082 ↗
• MalfunctionFeb 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE EACH OF ITEM ETPOUCH WAS RECEIVED IN DEFECTIVE, METAL LOOP FROM ONE POUCH WAS BROKEN. BAG WAS DISCONNECTED AND THE END WERE NOT TOGETHER. THE CUSTOMER DISPOSED OF THE DEFECTIVE PRODUCT. NO PATIENT CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378605 ↗
• InjuryFeb 9, 2026Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROBOT SURGERY, UPON REMOVAL AT END OF CASE, THE BAG BROKE INSIDE THE PATIENT. SPECIMEN FELL OUT OF BAG AND HAD TO BE REMOVED WITHOUT BAG. SURGEON HAD TO CREATE A BIGGER INCISION TO REMOVE SPECIMEN. WHEN SPECIMEN WAS RETRIEVED, IT WAS NOTED THAT A PIECE OF PLASTIC FROM THE ENDOPOUCH BAG WAS ATTACHED TO THE SPECIMEN. SURGEON HAD TO INCREASE INCISION SIZE TO REMOVE SPECIMEN. NEAR MISS EVENT THAT PIECE OF PLASTIC COULD HAVE REMAINED INSIDE THE PATIENT. NEAR THE END OF THE CASE, THE ROBOT WAS UNDOCKED AND REMOVED FROM PATIENT. SURGEON WAS REMOVING SPECIMEN WHICH WAS CONTAINED WITHIN THE ETHICON ENDOPOUCH RETRIEVER SPECIMEN BAG 10MM, WHEN THE POUCH BROKE INSIDE THE PATIENT AND THE PROSTATE SPECIMEN FELL OUT OF BAG. SURGEON AWARE AT TIME OF INCIDENT, SPECIMEN BAG WAS REMOVED FROM PATIENT AND HANDED TO SCRUB NURSE. SURGEON HAD TO REMOVE SPECIMEN WITHOUT BAG AND HAD TO CREATE A BIGGER INCISION SITE TO REMOVE SPECIMEN. WHEN SPECIMEN WAS RETRIEVED, IT WAS NOTED THAT A PIECE OF PLASTIC FROM THE ENDOPOUCH BAG WAS ATTACHED TO THE SPECIMEN. THE PIECE OF PLASTIC WAS LINED UP WITH THE SPECIMEN BAG BY SCRUB NURSE AND WAS NOTED TO SURGEON THAT THE PIECES LINED UP. SURGEO

  Patient problems: Foreign Body In Patient

  MAUDE report 24293983 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE 10MM ENDO POUCH, IT BROKE INSIDE THE PATIENT AND THE SPECIMEN FELL OUT AND HAD TO BE REMOVED WITHOUT BEING CONTAINED. THERE WAS ALSO A PIECE OF PLASTIC ATTACHED TO THE SPECIMEN, BUT THE STAFF CHECKED AND LINED UP THE PIECES AND THE SCRUB NURSE AND SURGEON WERE HAPPY THAT THEY HAD ALL PIECES OF THE BAG. THE PROCEDURE WAS DELAYED BY 10 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292463 ↗
• MalfunctionFeb 5, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A GALL BLADDER REMOVAL, ENDOPOUCH RETRIEVER IN PATIENT, REMOVING THE GALLBLADDER WHEN IT RIPPED. NO PATIENT CONSEQUENCES OR DELAY IN THE PROCEDURE WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267610 ↗