Endo Shears 176643Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884523000733), received between May 15, 2017 and Jan 21, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (13 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SHAFT SURFACE OF THE DEVICE WAS FOUND TO BE CRACKED. ANOTHER SAME TYPE OF DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140550 ↗
• MalfunctionJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, SPLIT INSULATION WAS OBSERVED ON THE DEVICE AND A HOLE WAS CAUSED IN THE GASTRIC ARTERY BY THE ENDO SHEARS. AN INSULATION ISSUE WAS ALSO IDENTIFIED WITH THE RETRACTABLE L HOOK, WHERE INSULATION FELL OFF OR DETACHED FROM THE SHAFT WHILE THE DEVICE WAS PLUGGED INTO A GENERATOR. ANOTHER LIGASURE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THE PATIENT EXPERIENCED A TEMPORARY INJURY AS A RESULT OF THE HOLE IN THE GASTRIC ARTERY, WHICH WAS MEDICALLY MANAGED BY CLIPPING THE ARTERY.

  Patient problems: Tissue Breakdown

  MAUDE report 24018178 ↗
• MalfunctionDec 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN TESTED PRIOR TO ENTERING THE BODY. THE SHEARS PART OF THE INSTRUMENT WOULD NOT OPEN AND CLOSE. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855073 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE DEVICE WAS OPERATED IN MONOPOLAR MODE, THE END OF THE SHAFT WAS BURNED. THIS ISSUE OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22427917 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE DEVICE WAS OPERATED IN MONOPOLAR MODE, THE END OF THE SHAFT WAS BURNED. THIS ISSUE OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22427807 ↗
• MalfunctionJun 20, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SHEARS CANNOT BE OPENED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22300449 ↗
• MalfunctionMar 26, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE SURGEON REALIZED THAT THERE WAS DIFFICULTY IN CLOSING THE JAWS OF BOTH DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980842 ↗
• MalfunctionMar 26, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE SURGEON REALIZED THAT THERE WAS DIFFICULTY IN CLOSING THE JAWS OF BOTH DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979138 ↗
• MalfunctionOct 10, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BAND REMOVAL, WHEN CUTTING ADHESION, THE DEVICE WOULD NOT CLOSE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908682 ↗
• MalfunctionJul 26, 2023Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE HANDLES OF THE DEVICE WERE BINDING, IT WAS ALSO REPORTED THAT THE JAWS OF THE DEVICE WAS TIGHT AND WOULD NOT OPEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402270 ↗
• MalfunctionJun 30, 2023Flare or Flash; Flare or Flash

  PLI 10: ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE WAS USED IN CUTTING THE VAGINAL CUFF AND RELEASING THE UTERUS, AND WHEN THE DOCTOR WAS FINISHING THE PROCEDURE, A SMALL FLAME IN THE CAVITY WAS OBSERVED. THE DEVICE WAS BURNED, AND A SMALL PART OF THE UTERUS (SPECIMEN) HAD A FIRST DEGREE BURN. THIS RESULTED IN TISSUE DAMAGE. IT WAS NOTED THAT THE BURN WAS NOT TREATED SINCE IT WAS ON THE SPECIMEN. TO COMPLETE THE CASE, AN ULTRASONIC DEVICE WAS USED.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 17238234 ↗
• MalfunctionJun 2, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE TIP OF THE JAW WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054471 ↗
• InjuryJan 17, 2023Break; Misfire; Flare or Flash; Break; Misfire; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSULATED SHAFT HAD A BREAK IN THE INSULATION WHICH RESULTED IN A MISFIRE AND BURN ON THE PATIENT'S UTERUS.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 16186914 ↗
• MalfunctionJun 16, 2022Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, WHEN THE DEVICE WAS USED, A SPARK OCCURRED IN THE PROTECTION AREA THAT WAS MADE OF PLASTIC FROM THE TIP. ANOTHER PRODUCT WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715749 ↗
• MalfunctionJul 19, 2021Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY, WHEN TRYING TO USE THE DEVICE, IT WOULD NOT GRASP PROPERLY. THE DEVICE WOULD NOT CLOSE, LOCKED UP AND WOULD NOT CLOSE. THE CLAMP WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194184 ↗
• MalfunctionJul 6, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIORRHAPHY, PRIOR TO USE THE DEVICE IN PATIENT, IT CAME DAMAGED INSIDE THE CLOSED PACKAGE. WHEN OPENING THE DEVICE IT WAS BROKEN AND MAKING OPENING AND CLOSING IMPOSSIBLE. THE DEVICE WAS REPLACED WITH A NEW PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124600 ↗
• MalfunctionMar 8, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS UNABLE TO OPEN OR CLOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436783 ↗
• MalfunctionMar 8, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE JAWS OF THE ENDOSCOPIC SHEARS WERE NOT OPENING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436740 ↗
• MalfunctionNov 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE USE OF THE MONOPOLAR ON CHOLECYSTECTOMY, THE PLASTIC COVERING THE BLADES BURNS. ANOTHER SCISSOR WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9329626 ↗
• MalfunctionJul 25, 2019Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING GENERAL LAPAROSCOPIC PROCEDURE, WHILE CUTTING OF TISSUE, THE DEVICE SHEERS WOULD NOT OPEN. IT WAS ALSO NOTED THAT THE DEVICE DID NOT GRASP PROPERLY. ANOTHER SHEER WAS OPENED AND THE CASE CONTINUED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828040 ↗
• MalfunctionJul 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE CAP OF THE ELECTRIC DEVICE CONNECTION TERMINAL PART OF THE SURGICAL SHEARS WAS FOUND TO BE DISCONNECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 8800948 ↗
• MalfunctionApr 29, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE SCISSORS NOT CUT NOT CLOSE. ANOTHER DEVICE WAS OPENED TO COMPLETE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560047 ↗
• MalfunctionMar 4, 2019Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS USED ON THE PATIENT, THE TIP WOULD NOT CLOSE. THE DEVICE DID NOT GRASP PROPERLY. THEY DISCARDED AND OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386162 ↗
• MalfunctionDec 3, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, ON THE MOBILIZATION OF THE UTERUS, THE SURGEON REPORTED THE JAWS WERE TOO STIFF TO OPEN AND CLOSE. THE SURGEON OPENED A SECOND UNIT FROM THE SAME BOX WHICH ALSO HAD THE SAME PROBLEM. THEY OPENED A COMPETITOR¿S PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8127207 ↗
• MalfunctionNov 12, 2018Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON NOTICED MELTING ON THE SHAFT OF THE DEVICE AFTER ITS USE IN THE PROCEDURE. THE CASE WAS FINISHED WHEN IT WAS NOTICED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8060156 ↗