ENDOPATH 5DCDRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705036000778), received between Feb 23, 2018 and May 14, 2026 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: EVALUATION OF THE PERFORMANCE AND SAFETY OF ENDOPATH 5 MM ELECTROSURGICAL INSTRUMENTS (MONOPOLAR). PERIOPERATIVE BLEEDING; ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR BLEEDING (APPENDIX 3 TABLE 3) DURING THE INDEX EPISODE OF CARE; 88. THERMAL INJURY/BURN; ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR THERMAL INJURY OR BURN (APPENDIX 3 TABLE 4) DURING THE INDEX EPISODE OF CARE; 2. SURGICAL OR SOFT TISSUE INJURY; ICD-10-CM DIAGNOSIS CODE (PRIMARY OR SECONDARY) FOR SURGICAL OR SOFT TISSUE INJURY (APPENDIX 3 TABLE 5) DURING THE INDEX EPISODE OF CARE; 131. THIS IS FOR ETHICON. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 25174997 ↗
• MalfunctionJul 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PACKAGE WAS DAMAGED AND NOT STERILIZED WHEN THE DEVICE WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716187 ↗
• MalfunctionJul 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SETUP FOR AN UNKNOWN PROCEDURE, A HOLE IN WRAPPER WAS FOUND PRIOR TO OPENING FOR CASE. NO PATIENT HARM DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660801 ↗
• MalfunctionJun 13, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE DID NOT WORK WHEN CONNECTED TO MONOPOLAR. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527949 ↗
• MalfunctionJun 13, 2024Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE DID NOT WORK WHEN CONNECTED TO MONOPOLAR. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527893 ↗
• MalfunctionMar 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE ENERGIZED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815709 ↗
• MalfunctionFeb 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WAS NOT SPREADING THE HEAT ON THE TISSUE. DEVICE REPLACED AND PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699025 ↗
• MalfunctionNov 15, 2023Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, AN UNEXPECTED BREAKING SOUND WAS HEARD, AND IT WAS FOUND THAT ONE SIDE OF THE JOINT PART OF THE JAW WAS BROKEN. X-RAY WAS PERFORMED, AND THERE WAS NO PIECE FOUND INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140815 ↗
• MalfunctionJul 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE JAWS WERE NOT ENGAGED AND WERE OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398242 ↗
• MalfunctionJul 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICES TIP WAS DEFLECTED WHEN OPEN THE PACKAGE. REPLACED WITH NEW DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398070 ↗
• MalfunctionFeb 8, 2023Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COLON RESECTION, IT WAS NOTICED THAT THE DISTAL PART OF THE DISSECTOR WAS DEFECTIVE, SEEING THAT THE JAWS DID NOT FIT AND WERE SEPARATED WITHOUT BEING ABLE TO BE USED. 3 DISSECTORS OPENED WITH SAME ISSUES. DELAYED PROCEDURE 5 MINUTES. PROCEDURE COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324266 ↗
• MalfunctionFeb 8, 2023Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COLON RESECTION, IT WAS NOTICED THAT THE DISTAL PART OF THE DISSECTOR WAS DEFECTIVE, SEEING THAT THE JAWS DID NOT FIT AND WERE SEPARATED WITHOUT BEING ABLE TO BE USED. 3 DISSECTORS OPENED WITH SAME ISSUES. DELAYED PROCEDURE 5 MINUTES. PROCEDURE COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324173 ↗
• MalfunctionFeb 8, 2023Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available; Manufacturing, Packaging or Shipping Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COLON RESECTION, IT WAS NOTICED THAT THE DISTAL PART OF THE DISSECTOR WAS DEFECTIVE, SEEING THAT THE JAWS DID NOT FIT AND WERE SEPARATED WITHOUT BEING ABLE TO BE USED. 3 DISSECTORS OPENED WITH SAME ISSUES. DELAYED PROCEDURE 5 MINUTES. PROCEDURE COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323923 ↗
• MalfunctionNov 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE JAWS ARE NOT TIGHT. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY. UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15817783 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS WERE VERY FLEXIBLE. THE CLAMP WAS FOUND TO BE DEFECTIVE AND COULD NOT COMPLETE THE INTERVENTION WITH IT. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680686 ↗
• MalfunctionSep 30, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISTAL TIP WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15516972 ↗
• MalfunctionSep 30, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISTAL TIP WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510170 ↗
• MalfunctionSep 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISTAL TIP WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473570 ↗
• MalfunctionSep 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456815 ↗
• InjuryAug 11, 2021Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION. PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, BLEEDING, BLOOD TRANSFUSION. SURGICAL INJURY. THERMAL INJURY. 30-DAY REOPERATION (BLEEDING-RELATED).

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12310451 ↗
• MalfunctionFeb 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT WAS PEELING OFF AT THE STEM. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346488 ↗
• MalfunctionFeb 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT WAS PEELING OFF AT THE STEM. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346476 ↗
• MalfunctionJun 20, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE JAWS OF THE DEVICE DID NOT MATCH PROPERLY WHEN THE SURGEON CHECKED THE DEVICE FUNCTIONALITY OUTSIDE THE PATIENT. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7618964 ↗
• MalfunctionFeb 26, 2018Break

  INSULATION / TIP IS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295898 ↗
• MalfunctionFeb 23, 2018Break

  DURING THE EXTRACTION OF THE DEVICE WAS RECOGNIZED THAT A 2 CM BLACK PLASTIC TIP WAS IN THE ABDOMEN. THE TIP IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292807 ↗