ENDOPATH EPS02Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705036012467), received between Mar 14, 2018 and May 8, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: AHN JS, PARK J, RYOO SB, KIM MJ, PARK JW, JEONG SY, PARK KJ. SAFETY AND EFFICACY OF FLEXIBLE ARTICULATED INSTRUMENT (ARTISENTIAL®) IN LAPAROSCOPIC SURGERY FOR RECTAL CANCER. BMC SURG. 2025 MAY 2;25(1):192. DOI: 10.1186/S12893-025-02841-9. PMID: 40312374; PMCID: PMC12046734. THE AIM OF THE STUDY IS TO ANALYZE THE SAFETY AND EFFICACY OF FLEXIBLE ARTICULATED INSTRUMENTS IN LAPAROSCOPIC SURGERY FOR RECTAL CANCER. THE MEDICAL RECORDS OF CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC RESECTION FOR RECTAL CANCER PERFORMED BY A SINGLE EXPERIENCED SURGEON BETWEEN 2012 AND 2022 WERE RETROSPECTIVELY ANALYZED. FINALLY, 93 PATIENTS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE USE OF ARTISENTIAL® INSTRUMENT (¿ARTICULATING GROUP¿) OR ITS NON-USE (¿STRAIGHT GROUP. THE ¿STRAIGHT GROUP¿ USED A CONVENTIONAL DEVICE: ENDOPATH® ELECTROSURGERY PROBE PLUS® II SYSTEM (EPS02/EPH02; ETHICON CO., OH, US).¿ REPORTED COMPLICATIONS INCLUDE: ENDOPATH® ELECTROSURGERY PROBE PLUS® II SYSTEM WOUND COMPLICATIONS (N=8) TREATMENT: NOT REPORTED INTRAPERITONEAL INFECTION (N=4) TREATMENT: NOT

  Patient problems: Failure to Anastomose; Insufficient Information; Obstruction/Occlusion; Peritonitis

  MAUDE report 25128335 ↗
• InjuryMay 8, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: AHN JS, PARK J, RYOO SB, KIM MJ, PARK JW, JEONG SY, PARK KJ. SAFETY AND EFFICACY OF FLEXIBLE ARTICULATED INSTRUMENT (ARTISENTIAL®) IN LAPAROSCOPIC SURGERY FOR RECTAL CANCER. BMC SURG. 2025 MAY 2025(1):192. DOI: 10.1186/S12893-025-02841-9. PMID: 40312374; PMCID: PMC12046734. THE AIM OF THE STUDY IS TO ANALYZE THE SAFETY AND EFFICACY OF FLEXIBLE ARTICULATED INSTRUMENTS IN LAPAROSCOPIC SURGERY FOR RECTAL CANCER. THE MEDICAL RECORDS OF CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC RESECTION FOR RECTAL CANCER PERFORMED BY A SINGLE EXPERIENCED SURGEON BETWEEN 2012 AND 2022 WERE RETROSPECTIVELY ANALYZED. FINALLY, 93 PATIENTS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE USE OF ARTISENTIAL® INSTRUMENT (¿ARTICULATING GROUP¿) OR ITS NON-USE (¿STRAIGHT GROUP. THE ¿STRAIGHT GROUP¿ USED A CONVENTIONAL DEVICE: ENDOPATH® ELECTROSURGERY PROBE PLUS® II SYSTEM (EPS02/EPH02; ETHICON CO., OH, US).¿ REPORTED COMPLICATIONS INCLUDE: ENDOPATH® ELECTROSURGERY PROBE PLUS® II SYSTEM WOUND COMPLICATIONS (N=8), TREATMENT: NOT REPORTED, INTRAPERITONEAL INFECTION (N=4), TREATMENT: N

  Patient problems: Failure to Anastomose; Insufficient Information; Obstruction/Occlusion; Peritonitis

  MAUDE report 25124893 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BOVIE TIP WAS ISOLATED WHILE OPERATION. REMOVING THE BOBBY TIP DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850452 ↗
• MalfunctionSep 11, 2025Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, ALTHOUGH THE ROTATE KNOB AT HAND WAS ROTATED, THE TIP OF THE DEVICE DID NOT ROTATE. THE METAL OF THE SHAFT AXIS AND THE BONDING OF THE PLASTIC AXIS CAME OFF, AND THE DEVICE SPUN. NO PIECES WERE FELL INTO 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 23025215 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING OB-GYN PROCEDURE, THE ELECTRODE CAME OFF THE SHAFT WAS MOVED IN AND OUT BY A NURSE. IT HAPPENED BEFORE THE PROCEDURE BEGAN, WHILE THE NURSE WAS SETTING. 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 20835539 ↗
• MalfunctionNov 6, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC COLECTOMY, WHEN TRIED TO OPEN THE PACKAGE, IT WAS FOUND THAT THE MAIN BODY WAS DAMAGED AND THERE WAS A FEAR OF AIR IN IT (THE STERILE PACKAGING WAS BROKEN), SO IT WAS REPLACED WITH A NEW ONE. 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 20621457 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC NEPHRECTOMY, ABOUT 2 HOURS AFTER STARTING THE PROCEDURE, THE ELECTRODE HAD DIFFICULTY IN BEING PULL IN AND OUT. WHEN INSERTING THE ELECTRODE, APPLYING SUCTION, THERE WAS A SENSATION OF SLIPPING IN THE DIRECTION TO THE TIP, AND THE ELECTRODE CAME OFF. REPLACING THE SHAFT, THE DEVICE COULD BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914474 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING OB-GYN PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN DURING USING THE DEVICE. NO PIECES WERE LEFT 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 19842005 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE DEVICE WAS BROKEN WHEN IT WAS TAKEN IN AND OUT. 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 19800797 ↗
• MalfunctionJul 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ELECTRODE CAME OUT FROM THE SHAFT WHEN THE DEVICE WAS SET BEFORE USE. 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 17335320 ↗
• MalfunctionFeb 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE ELECTRODE WAS DETACHED OFF FROM THE SHAFT. 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 16429397 ↗
• MalfunctionAug 9, 2022Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE INSTRUMENT WAS NOT WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191306 ↗
• MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE DEVICE BROKE. NO PIECES FELL INTO 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 13966175 ↗
• MalfunctionAug 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS DIFFICULTY SLIDING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336339 ↗
• MalfunctionAug 2, 2021Arcing of Electrodes; Arcing of Electrodes

  IT WAS REPORTED THAT, DURING A THORACOSCOPIC ESOPHAGECTOMY, THE DEVICE DID NOT COAGULATE. 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 12264517 ↗
• MalfunctionJun 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN OB-GYN PROCEDURE, THE ELECTRODE BROKE WHEN THE NURSE WAS CLEANING THE SCORCH ON THE ELECTRODE. THE ISSUE OCCURRED AFTER THE DEVICE WAS USED FOR 1 TO 2 HOURS. NO PIECES FELL INTO 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 12060569 ↗
• MalfunctionMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SPATULA TIP DETACHED ALTHOUGH THE SURGEON HAD ONLY USED IT 10 TIMES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588936 ↗
• MalfunctionDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP SIGMA THE FRONT OF THE SPATULA WAS BENT AND HAS FALLEN OUT. 3 DEVICES WERE OPENED. ONLY AT THE 4TH, DID THE DEVICE WORK AND THE SURGERY COULD BE COMPLETED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003585 ↗
• MalfunctionDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP SIGMA THE FRONT OF THE SPATULA WAS BENT AND HAS FALLEN OUT. 3 DEVICES WERE OPENED. ONLY AT THE 4TH, DID THE DEVICE WORK AND THE SURGERY COULD BE COMPLETED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003532 ↗
• MalfunctionDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP SIGMA THE FRONT OF THE SPATULA WAS BENT AND HAS FALLEN OUT. 3 DEVICES WERE OPENED. ONLY AT THE 4TH, DID THE DEVICE WORK AND THE SURGERY COULD BE COMPLETED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003249 ↗
• InjuryAug 31, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC OB-GYN PROCEDURE, THE DEVICE WAS ACTIVATED WHEN THE DEVICE TIP WAS NOT TOUCHING THE TARGET TISSUE AND CAPACITIVE COUPLING HAD OCCURRED OUTSIDE THE VISUAL FIELD OF SCOPE. IN THIS TIME, THE SHAFT PART WAS TOUCHING THE INTESTINE AND MESENTERY. THE INTESTINE WAS DAMAGED AND ILEOCECAL PERFORATION WAS FOUND AFTER THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bowel Perforation; Injury

  MAUDE report 10472193 ↗
• MalfunctionApr 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT WAS USED FOR MONOPOLAR COAGULATION AND CUTTING, HOWEVER, IT DIDN'T COAGULATE PROPERLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007863 ↗
• MalfunctionSep 6, 2019Activation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE DEVICE WAS NOT ACTIVATED AND COULD NOT CUT THE TISSUE ALTHOUGH IT COAGULATED DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972777 ↗
• MalfunctionMar 14, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS NOT ACTIVATED. 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 7338093 ↗