Endo Mini-Shears 174309Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884523000689), received between Jan 15, 2018 and Feb 7, 2024 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOSCOPIC MASTECTOMY, THE SILICONE PAD ON THE FIRST DEVICE BURNED DURING THE PEELING CAUTERY. A NEW DEVICE OF THE SAME TYPE WAS USED. HOWEVER, SIMILAR SILICONE PAD DAMAGE OCCURRED DURING THE FINAL STAGES OF PEELING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664478 ↗
• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOSCOPIC MASTECTOMY, THE SILICONE PAD ON THE FIRST DEVICE BURNED DURING THE PEELING CAUTERY. A NEW DEVICE OF THE SAME TYPE WAS USED. HOWEVER, SIMILAR SILICONE PAD DAMAGE OCCURRED DURING THE FINAL STAGES OF PEELING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664464 ↗
• InjuryJul 1, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING SEPARATION OPERATION OF THE AREA AROUND THE LIVER IN A LAPAROSCOPIC HEPATECTOMY, WHEN THE PRODUCT WAS USED IN THE ROTICULATE STATE, IT ACTIVATED FROM THE INNER SIDE OF THE ARTICULATION PART. THE LIVER WAS BURNED AS A RESULT, HOWEVER, THE SURGERY WAS COMPLETED WITH NORMAL HEMOSTASIS OPERATION. AFTERWARDS, WHEN THE PRODUCT WAS CHECKED OUTSIDE THE BODY, THE INNER SIDE OF THE ARTICULATION PART WAS FOUND TO BE IN THE STATE THAT SEEMED HAD MELTED, SO THEY STOPPED USING THE PRODUCT. THE PRODUCT WAS REPLACED WITH A NEW ONE.

  Patient problems: Burn(s); Unspecified Tissue Injury

  MAUDE report 14889693 ↗
• MalfunctionFeb 19, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BAND REMOVAL, THE TRANSPARENT PLASTIC MEMBRANE THAT COMES OUT OF THE SHAFT WHEN THE ROTICULATOR JAW IS ACTIVATED, TORN UNEXPECTEDLY. THE SURGEON USED THE SAME DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347676 ↗
• MalfunctionApr 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO LOW ANTERIOR RESECTION PROCEDURE, THE SHEATH OF THE SHAFT CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9953507 ↗
• MalfunctionFeb 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WHITE PLASTIC COVER WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769316 ↗
• MalfunctionFeb 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WHITE PLASTIC COVER WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769302 ↗
• MalfunctionFeb 27, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S WHITE PLASTIC COVER WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765311 ↗
• MalfunctionFeb 27, 2020Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 9763219 ↗
• MalfunctionFeb 27, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHITE PLASTIC COVER WAS BROKEN ON THE TWO DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763207 ↗
• MalfunctionFeb 27, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHITE PLASTIC COVER WAS BROKEN ON THE TWO DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763203 ↗
• MalfunctionSep 9, 2019Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE STAPLER DID NOT FIRE. IT WAS ALSO REPORTED THAT THE SURGICAL SHEARS HAD NO BITE DUE TO SPLIT JOINT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974877 ↗
• MalfunctionApr 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING TRANS-ABDOMINAL PRE-PERITONEAL REPAIR (TAPP), THE ARTICULATION PART (TRANSPARENT PART) BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522965 ↗
• MalfunctionSep 26, 2018Break; Mechanical Problem; Break; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHITE PLASTIC COVER WAS BROKEN. ALSO THE DEVICE DID NOT GRASP PROPERLY AND THE HANDLES DID NOT BIND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910103 ↗
• MalfunctionFeb 7, 2018Break; Break

  ACCORDING TO THE REPORTER, THE ISSUE OCCURRED PRIOR TO THE PROCEDURE - TAP (TRANSABDOMINAL PREPERITONEAL REPAIR). THE DEVICE WAS REMOVED FORM THE PACKAGING AND WAS DISCOVERED THAT THE SHEATH WAS FRAYED AND NOT IN THE STRAIGHT POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7250313 ↗
• MalfunctionJan 15, 2018Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A THORACOSCOPIC LOBECTOMY PROCEDURE. AFTER REMOVING THE DEVICE FROM THE PACKAGING, TRIED TO RETRACT THE ARTICULATED TIP BY ROTATING THE CENTER ROD DIAL. BUT THE PLASTIC PART AT THE TIP OF THE DEVICE BROKE AND WAS CAUGHT BY THE DEVICE. IT COULD NOT BE RETRACTED. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW DEVICE WAS OPENED AND THE PROCEDURE COMPLETED WITH NO FURTHER PROBLEMS. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191936 ↗