Endo ShearsRecalls & reported problems across all models
Covidien LP · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 2 models of Endo Shears by Covidien LP in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between May 15, 2017 and Jan 21, 2026 — classified as 2 injuries, 34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Endo Shears problems
Device problems
- Difficult to Open or Close13
- Failure to Cut7
- Break6
- Mechanical Problem4
- Adverse Event Without Identified Device or Use Problem3
- Flare or Flash3
- Dull, Blunt2
- Melted2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient3
- Burn(s)2
- No Patient Involvement2
- Unspecified Tissue Injury2
- Burn, Thermal1
- No Code Available1
Endo Shears models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Endo Shears 176643ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES34 reports
- Endo Shears 174601ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
Recent Endo Shears adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 22, 2024Failure to Cut; Failure to Cut
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS NOT CUTTING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556401 ↗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 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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