Endo Dissect 174213Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884523000665), received between Aug 31, 2017 and Feb 28, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PLASTIC AROUND THE STAPLER HEAD SPLIT DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 18797660 ↗
• MalfunctionFeb 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY THE PLASTIC AROUND THE STAPLER HEAD SPLIT DURING USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785043 ↗
• MalfunctionJul 20, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AFTER REPEATEDLY TURNING THE HANDLE OF THE GRASPERS AND THE DISSECT OF THE RELEVANT PRODUCT, ARTICULATING THE TIP, TURNING THE HANDLE IN THE OPPOSITE DIRECTION, AND PLACING IT TO A STRAIGHT POSITION, THE TRANSPARENT FILM FROM THE ARTICULATION PART CAME OFF. A NEW PRODUCT WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068014 ↗
• MalfunctionSep 30, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A RECTAL PROCEDURE, WHEN THE DEVICE WAS OPENED, THE FLEXIBLE PART AT THE TIP WAS ALREADY BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10606363 ↗
• MalfunctionMar 24, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SHAFT SHELL OF THE TWO DEVICES HAD BEEN PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9872158 ↗
• MalfunctionMar 24, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SHAFT SHELL OF THE TWO DEVICES HAD BEEN PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9872139 ↗
• MalfunctionFeb 5, 2020Break; Break

  ACCORDING TO THE REPORTER, THE PLASTIC COVER OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9674205 ↗
• MalfunctionAug 1, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, PART OF THE JAW WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8850743 ↗
• MalfunctionAug 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE THE WHITE ARTICULATING LEVER WAS BROKEN.

  Patient problems: No Information

  MAUDE report 8850159 ↗
• MalfunctionJan 3, 2019Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLEDOCHOLITHOTOMY, THE OPENING OF THE END GRASP WAS NOT GOOD. IT WAS ALSO REPORTED THAT THE TIP OF THE SECOND DEVICE WAS DEVIATED. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8213017 ↗
• MalfunctionDec 27, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A CASE OF EXCISION OF MEDIASTINAL LESION AND THORACOSCOPY, BOTH DEVICE HAD THEIR COATING PEELED-OFF AFTER JUST ONE USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199934 ↗
• MalfunctionFeb 20, 2018Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE DEVICES WERE BEING USED FOR THE DISSECTION. BOTH DEVICES HAD A BURN AT THE END OF THE ROTICULATOR. BOTH DEVICES WERE ABLE TO GRASP PROPERLY AND THE HANDLES DID NOT BIND. THE PATIENT'S MEDICAL HISTORY IS SMOKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283988 ↗
• MalfunctionAug 31, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WOULD NOT OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836373 ↗