N/A (REF 5DCS)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Endopath Curved Scissors w/Unipolar Cautery · Class 2
Quick summary
This is a reprocessed Stryker Endopath laparoscopic scissor with cautery, used to cut tissue during minimally invasive surgery. The 23 reports naming it mostly describe scissors that were too dull to cut or whose insulating coating peeled off during procedures, in one case leaving a fragment inside the patient; one report mentions a colon burn. There were 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00885825013288), received between Nov 3, 2016 and Nov 27, 2023 — classified as 3 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut14
- Dull, Blunt3
- Peeled/Delaminated2
- Device Operates Differently Than Expected1
- Difficult to Open or Close1
- Difficult to Open or Remove Packaging Material1
- Material Fragmentation1
- Mechanics Altered1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient9
- Insufficient Information2
- Bowel Burn1
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2023
WHILE DOING A COLON RESECTION, IT WAS NOTICED THAT THE PLASTIC INSULATION AT THE TIP OF THE STRYKER SCISSORS WAS PEELING OFF LEAVING EXPOSED METAL, NO SPARKS WERE SEEN.
Patient problems: Insufficient Information
MAUDE report 18208838 ↗MalfunctionApr 22, 2022Peeled/Delaminated
THE INSULATION COATING, FROM THE STRYKER SUSTAINABILITY SOLUTIONS ENDOPATH 5MM ENDOSCOPIC REPROCESSED SCISSOR, PEELED BACK AT APEX WHERE HINGE AND CLOSING MECHANISM ON SCISSOR COME TOGETHER.
Patient problems: Insufficient Information
MAUDE report 14188408 ↗InjurySep 16, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE INSULATION BROKE OFF FROM THE LAPAROSCOPIC SCISSORS DURING PROCEDURE. THE INSULATION FELL INTO THE PATIENT AND WAS NOT RETRIEVED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 10544229 ↗InjuryAug 4, 2020Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THE LAPAROSCOPIC SCISSORS WERE BEING USED TO REMOVE THE TISSUE AROUND THE UTERUS. THE END OF THE SCISSORS GOT TOO HOT. AS THEY WERE REMOVING THE UTERUS THE DR. NOTICED THERE WAS A BURN ON THE COLON. HE DID HAVE TO SUTURE IT TO ENSURE IT WAS REINFORCED. THE BURN WAS ATTRIBUTED TO THE STRYKER DEVICE AND THE PHYSICIAN SUTURED THE BURN TO PREVENT FURTHER INJURY. THERE WAS A MARK ON THE SCISSORS FROM THE HEAT AND THE COLON. THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY ADDITIONAL ADVERSE CONSEQUENCES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: Bowel Burn
MAUDE report 10365653 ↗MalfunctionDec 21, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS (5DCS) ARE DULL. NO OTHER INFORMATION IS AVAILABLE BY THE FACILITY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7140444 ↗MalfunctionNov 28, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CURVED LAPAROSCOPIC SCISSORS DID NOT CUT THE TISSUE AS EXPECTED. THE SURGEON FELT THAT THE DEVICE WAS NOT SHARPENED TO STANDARD. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THERE WAS NO UNEXPECTED BLEEDING REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7065385 ↗MalfunctionNov 28, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS FAILED TO CUT. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS SPECIFIC EVENT. HOWEVER, NO OTHER INFORMATION WAS PROVIDED FROM THE FACILITY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7063775 ↗MalfunctionSep 25, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED 5 DCS SCISSORS WERE NOT SHARP ENOUGH DURING A CASE. THE DOCTOR BENT THE DEVICE IN FRUSTRATION AFTER IT FAILED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6892384 ↗InjuryAug 24, 2017Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT WHEN USING THE SCISSOR FOR CAUTERY THROUGH A TROCAR GRIP CANNULA THE PATIENT JUMPED WITH ACTIVATION. THE INSTRUMENT WAS REMOVED AND IT WAS NOTED THAT THERE WAS INSULATION MISSING AND EXPOSED METAL ON INSTRUMENT SHAFT. THE CANNULA WAS REMOVED. IRRIGATION WITH NACL 0.9% AND TISSUE ASSESSMENT WAS PERFORMED. IT WAS NOTED THAT LITTLE BLACK FRAGMENTS OFF INSTRUMENT WERE LEFT INSIDE THE PATIENT. THE CUSTOMER WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION, HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6819490 ↗MalfunctionAug 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE LAPAROSCOPIC SCISSOR IS DEFECTIVE. THE COMPLAINANT IS UNAWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6815879 ↗MalfunctionAug 21, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS WERE DULL. THE LAPAROSCOPIC SCISSORS WERE REPLACED AND THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6809183 ↗MalfunctionAug 3, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS DID NOT CUT AND THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6765651 ↗MalfunctionAug 3, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS DID NOT CUT AND THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6765543 ↗MalfunctionJun 5, 2017Failure to Cut; Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS WERE NOT CUTTING. THERE WAS A FIVE MINUTE DELAY TO GRAB A NEW DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6613591 ↗MalfunctionApr 17, 2017Failure to Cut
IT WAS REPORTED THE LAPAROSCOPIC SCISSORS WOULD NOT CUT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6498966 ↗MalfunctionMar 9, 2017Dull, Blunt
IT WAS REPORTED THE LAPAROSCOPIC SHEARS WERE NOT SHARP. THE SHEARS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6393626 ↗MalfunctionMar 6, 2017Failure to Cut
IT WAS REPORTED THE SURGEON WAS UNABLE TO CUT WITH THE LAPAROSCOPIC SCISSORS. THE DEVICE WAS REPLACED, LEADING TO A FEW MINUTES DELAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6380615 ↗MalfunctionJan 23, 2017Naturally Worn
IT WAS REPORTED THE DOCTORS COMPLAINED THE SCISSORS WERE DULL. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6271033 ↗MalfunctionJan 5, 2017Dull, Blunt; Failure to Cut
IT WAS REPORTED THE SCISSORS WERE DULL AND WOULD NOT CUT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6227228 ↗MalfunctionDec 21, 2016Failure to Cut; Difficult to Open or Close
IT WAS REPORTED THE SCISSORS DID NOT OPEN OR CUT. THE DEVICE WAS QUICKLY REMOVED FROM THE CASE AND REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6196242 ↗MalfunctionDec 6, 2016Failure to Cut; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE LAPAROSCOPIC SCISSORS WOULD NOT CUT AND THE JAWS WERE DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6149901 ↗MalfunctionNov 30, 2016Failure to Cut
IT WAS REPORTED THAT DURING THE PROCEDURE THE LAPAROSCOPIC SCISSORS INITIALLY CUT, BUT WOULD NOT CUT ON THE SECOND ATTEMPT. THE SCISSORS WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6136669 ↗MalfunctionNov 3, 2016Dull, Blunt; Mechanics Altered
IT WAS REPORTED THE 5DCS WAS DULL AND WOULD NOT CUT CORRECTLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED TO RETRIEVE ANOTHER 5DCS WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 6075996 ↗
Other ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED devices
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- Medline LF1844CRMedline Industries, Inc. · Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed2 recalls1 report
- N/A LF1837Stryker Sustainability Solutions, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED70 reports
- MEDLINE LF1212ACRMedline Industries, Inc. · Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed1 recall8 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.