Endo Dissect 176645Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884523000740), received between Sep 29, 2016 and Apr 20, 2026 — classified as 8 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (56 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Failure to Align

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, FROM THE TIME THE TWO DEVICES WERE OPENED, THE DEVICES' JAWS WERE MISALIGNED. TO RESOLVE THE ISSUE, THE DEVICE JAW WAS MOVED AND READJUSTED TO FUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931315 ↗
• MalfunctionApr 17, 2026Mechanical Problem; Failure to Align

  ACCORDING TO THE REPORTER DURING BILATERAL INGUINAL HERNIORRHAPHY, THE JAW WAS MISALIGNED AND WHEN ATTEMPTING TO CLOSE, IT FAILED TO SECURELY GRASP THE TISSUE. THREE PACKAGES WERE OPENED UNTIL ONE WAS FOUND THAT ACTUALLY WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908120 ↗
• MalfunctionApr 17, 2026Mechanical Problem; Failure to Align

  ACCORDING TO THE REPORTER DURING BILATERAL INGUINAL HERNIORRHAPHY, THE JAW WAS MISALIGNED AND WHEN ATTEMPTING TO CLOSE, IT FAILED TO SECURELY GRASP THE TISSUE. THREE PACKAGES WERE OPENED UNTIL ONE WAS FOUND THAT ACTUALLY WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908096 ↗
• MalfunctionApr 17, 2026Mechanical Problem; Failure to Align

  ACCORDING TO THE REPORTER DURING BILATERAL INGUINAL HERNIORRHAPHY, THE JAW WAS MISALIGNED AND WHEN ATTEMPTING TO CLOSE, IT FAILED TO SECURELY GRASP THE TISSUE. THREE PACKAGES WERE OPENED UNTIL ONE WAS FOUND THAT ACTUALLY WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907997 ↗
• MalfunctionMar 2, 2026Difficult to Open or Close; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PADDLE PART DID NOT OPEN FROM THE BEGINNING. ANOTHER DISSECTOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 24492268 ↗
• MalfunctionFeb 26, 2026Electrical /Electronic Property Problem; Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE NEW DISSECTOR DID NOT COAGULATE AND NOTICED THERE WAS A SMALL MISALIGNMENT. A NEW ONE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455905 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375445 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375444 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375433 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375428 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375407 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375405 ↗
• MalfunctionFeb 18, 2026Failure to Align

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAWS WERE DEFORMED AND DID NOT FIT TOGETHER. THE ISSUE OCCURRED ON SEVEN DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375392 ↗
• MalfunctionFeb 17, 2026Failure to Align

  IT WAS REPORTED THAT PRIOR TO USE FOR A LAPAROSCOPY SURGERY, WHILE OPENING A NEW DISSECTOR PACK, THE SURGEON OBSERVED THAT THE JAWS/TIP WERE MISALIGNED. THE DEVICE WAS REMOVED, AND ANOTHER NEW DISSECTOR PACK FROM ANOTHER BRAND WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367236 ↗
• MalfunctionAug 18, 2025Difficult or Delayed Positioning; Difficult to Open or Close; Mechanics Altered; Difficult or Delayed Positioning; Difficult to Open or Close; Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, WHILE DISSECTING THE OMENTUM TISSUE, THE TIP WAS NOT FULLY CLOSED, THE GREEN ROTATE BUTTON COULD NOT ROTATE SMOOTHLY, AND THE HANDLE WAS HARD TO COMPRESS OR SQUEEZE AND COULD NOT OPEN WIDE. A NEW DEVICE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826833 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ELECTRODE SEPARATED FROM THE BACK OF THE INSTRUMENT AT THE MOMENT THE DOCTOR PASSED THE DEVICE TO THE INSTRUMENTALIST. THERE WAS NO ELECTRODE BREAKAGE AND NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE DOCTOR REPOSITIONED THE POSTERIOR ELECTRODE IN THE CLAMP TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505074 ↗
• MalfunctionMay 1, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING THE RESECTION OF THE CALOT TRIANGLE, THE JAWS WERE UNBALANCED. THE ISSUE WAS RESOLVED BY USING A NEW INSTRUMENT FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946870 ↗
• InjuryFeb 19, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY WHILE DISSECTING THE FREE OMENTUM, THE SURGEON HAD A PROBLEMS WITH THREE DISSECTORS DUE TO THE JAWS OF THE DISSECTOR DID NOT FULLY CLOSE. AS A RESOLUTION THE SURGEON USED ANOTHER DEVICE FROM A DIFFERENT M MANUFACTURER. IT WAS ALSO NOTED THAT THERE WAS AN ADDITIONAL OPERATION PERFORMED TO THE PATIENT.

  Patient problems: Tissue Breakdown

  MAUDE report 21417111 ↗
• InjuryFeb 19, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY WHILE DISSECTING THE FREE OMENTUM, THE SURGEON HAD A PROBLEMS WITH THREE DISSECTORS DUE TO THE JAWS OF THE DISSECTOR DID NOT FULLY CLOSE. AS A RESOLUTION THE SURGEON USED ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS ALSO NOTED THAT THERE WAS AN ADDITIONAL OPERATION PERFORMED TO THE PATIENT.

  Patient problems: Tissue Breakdown

  MAUDE report 21417002 ↗
• InjuryFeb 19, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY WHILE DISSECTING THE FREE OMENTUM, THE SURGEON HAD A PROBLEMS WITH THREE DISSECTORS DUE TO THE JAWS OF THE DISSECTOR DID NOT FULLY CLOSE. AS A RESOLUTION THE SURGEON USED ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS ALSO NOTED THAT THERE WAS AN ADDITIONAL OPERATION PERFORMED TO THE PATIENT.

  Patient problems: Tissue Breakdown

  MAUDE report 21414063 ↗
• MalfunctionNov 27, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, A LAPAROSCOPIC PROCEDURE, THE JAWS OF THE THREE HAND INSTRUMENTS DID NOT FIT OR CLOSE PROPERLY. THE ISSUE WAS DETECTED AT THE START OF THE SURGERY WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. AN INVENTORIABLE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798162 ↗
• MalfunctionNov 27, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, A LAPAROSCOPIC PROCEDURE, THE JAWS OF THE THREE HAND INSTRUMENTS DID NOT FIT OR CLOSE PROPERLY. THE ISSUE WAS DETECTED AT THE START OF THE SURGERY WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. AN INVENTORIABLE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798115 ↗
• MalfunctionNov 27, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, A LAPAROSCOPIC PROCEDURE, THE JAWS OF THE THREE HAND INSTRUMENTS DID NOT FIT OR CLOSE PROPERLY. THE ISSUE WAS DETECTED AT THE START OF THE SURGERY WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. AN INVENTORIABLE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798097 ↗
• MalfunctionNov 4, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN DISSECTING THE FREE OMENTUM, THE TIP OF THE FOUR DEVICES WERE NOT FULLY CLOSED. THE USER OPENED ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604796 ↗
• MalfunctionNov 4, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN DISSECTING THE FREE OMENTUM, THE TIP OF THE FOUR DEVICES WERE NOT FULLY CLOSED. THE USER OPENED ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598355 ↗