ENDOPATH EPH02Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705036012443), received between Jan 11, 2018 and Sep 2, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  It was reported that, during a total laparoscopic hysterectomy with bilateral salpingectomy for uterine fibroids, bleeding from the port site was cauterized using a right-angle electrode of the Probe Plus during wound closure. An electric current ran through the muscle retractor that was placed in the surgical field at that time, causing a second-degree burn. The attending physician's opinion is that it may have been an electrical discharge. The patient is female, but it is currently confirming the treatment she received for this incident, her condition after treatment, and the patient background information. No further information is available.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50255379 ↗
• InjuryMay 8, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHO CW, RHU J, KIM KS, OH N, CHOI GS. COGNITIVE TASK ANALYSIS-BASED EDUCATION AND EXPANSION OF PURE LAPAROSCOPIC DONOR HEPATECTOMY FOR THE NEXT GENERATION: A COMPARATIVE STUDY OF SURGICAL OUTCOMES BETWEEN EXPERT AND FELLOWSHIP-TRAINED SURGEONS. SURG ENDOSC. 2026 FEB;40(2):1694-1703. DOI: 10.1007/S00464-025-12466-X. EPUB 2026 JAN 26. PMID: 41586911. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF COGNITIVE TASK ANALYSIS (CTA)-BASED TRAINING IN DEVELOPING TECHNICAL SKILLS AND A PROFESSIONAL MINDSET TO ENABLE FELLOWSHIP-TRAINED SURGEONS (FTSS) TO PERFORM PLDH FOR ALDLT AND TO COMPARE SURGICAL OUTCOMES WITH THOSE OF EXPERT SURGEONS. FROM DECEMBER 2016 TO DECEMBER 2023, A TOTAL OF 55 CASES OF PLDH AND ALDLT PERFORMED BY THREE FTSS WERE COMPARED WITH THOSE FROM 462 CASES PERFORMED BY ONE EXPERT SURGEON. THERE WERE (N=55) IN FTS GROUP, WITH 34 (61.8%)MALES AND 21 (38.2%) FEMALES WITH THE MEAN AGE OF 38±13 YEARS OLD, ON THE OTHER HAND, THERE WERE (N=462) IN EXPERT GROUP WITH 259 (56.15) MALES AND 203 (43.9%) FEMALES WITH THE MEAN AGE OF 37±14 YEARS OLD. EPS ENDOPATH¿ ELECTROSURGERY PROBE PLUS¿ II

  Patient problems: Insufficient Information

  MAUDE report 25129992 ↗
• InjuryApr 6, 2026Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM TS, KIM KH, AN CH, KIM JS. SINGLE CENTER EXPERIENCES OF NEEDLESCOPIC GRASPER ASSISTED SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY FOR GALLBLADDER BENIGN DISEASE: COMPARISON WITH CONVENTIONAL 3-PORT LAPAROSCOPIC CHOLECYSTECTOMY. ANN SURG TREAT RES. 2016 NOV;91(5):233-238. DOI: 10.4174/ASTR.2016.91.5.233. EPUB 2016 OCT 31. PMID: 27847795; PMCID: PMC5107417. THE AIM OF THE STUDY IS TO INTRODUCE OUR TECHNIQUE NEEDLESCOPIC GRASPER ASSISTED SILC (NSILC) AND EVALUATE THE SAFETY AND FEASIBILITY OF THIS TECHNIQUE COMPARED WITH THE CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY (CLC). FROM OCTOBER 2011 TO DECEMBER 2012, 485 PATIENTS WHO UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE AND CHRONIC CHOLECYSTITIS AT UIJEONGBU ST. MARY'S HOSPITAL, THE CATHOLIC UNIVERSITY OF KOREA WERE INCLUDED IN THIS STUDY. CLC WAS PERFORMED IN 252 PATIENTS AND NEEDLESCOPIC ASSISTED SINGLE NSILC WAS PERFORMED IN 233 PATIENTS. NSILCS WERE PERFORMED ROUTINELY THROUGH THE SILS PORT (COVIDIEN, DUBLIN, IRELAND) WITH A SNAKE LIVER RETRACTOR TO PUSH UP THE HEPATIC HILUM IN THE CEPHALAD DIRECTION; AND ENDOPATH ELECTROSURGERY PR

  Patient problems: Insufficient Information; Perforation of Vessels; Seroma; Unspecified Tissue Injury

  MAUDE report 24793095 ↗
• MalfunctionMar 7, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, IT WAS FOUND THAT THE PACKAGE WAS BROKEN BEFORE USE. 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 21547367 ↗
• MalfunctionNov 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, TYVEK WAS FIRMLY ADHERED TO THE CONTAINER BOX, AND IT WAS PEELING OFF. 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 20666491 ↗
• MalfunctionNov 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE AN UNKNOWN PROCEDURE, TYVEK WAS FIRMLY ADHERED TO THE CONTAINER BOX, AND IT WAS PEELING OFF. 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 20657261 ↗
• MalfunctionSep 18, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY: TLH, WHEN THE INCISION BUTTON OF AN ELECTRIC KNIFE WAS PRESSED, IT WAS LEFT TO ENERGIZE EVEN AFTER THE BUTTON WAS RELEASED. THE GENERATOR WAS COMPETITIVE 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 20250543 ↗
• MalfunctionMay 30, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, A NURSE NOTICED THAT THE CODE OF THE DEVICE WAS DAMAGED. IT WAS OCCURRED WHEN THE DEVICE WAS READY, SO THE DEVICE WAS NOT USED. 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 19424013 ↗
• MalfunctionJan 18, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC OB-GYN PROCEDURE, THE DEVICE CONTINUED TO SUCTION ALTHOUGH THE SUCTION BUTTON WAS NOT PRESSED. THE DOCTOR COMMENTED THAT CONTINUED INTRAOPERATIVE SUCTIONING COULD CAUSE A DANGEROUS SITUATION WITH REDUCED INSUFFLATION PRESSURE AND LOSS OF VISION. 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 18533845 ↗
• MalfunctionApr 11, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE DEVICE STARTED SUCTIONING ALTHOUGH THE ACTIVATION BUTTON WAS NOT PRESSED. 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 14074147 ↗
• MalfunctionJul 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BOX FOR THIS PRODUCT AS A DISPENSER IS NOT WORKING. THE BOX IS FLIMSY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197814 ↗
• MalfunctionDec 16, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS WORKING WITHOUT PRESSING A BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019772 ↗
• MalfunctionJun 11, 2020Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT BEFORE AN OB-GYN SURGERY, THE DEVICE IRRIGATED EVEN THOUGH THE IRRIGATION BUTTON WAS NOT PRESSED. THE DEVICE WAS NOT USED FOR 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 Consequences Or Impact To Patient

  MAUDE report 10146116 ↗
• MalfunctionApr 29, 2020Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WATER LEAKED, EVEN THOUGH THE BUTTON WAS NOT PRESSED AFTER THE DEVICE WAS ACTIVATED. 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 10011630 ↗
• MalfunctionOct 28, 2019Self-Activation or Keying

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE COAGULATION BUTTON WAS ACTIVATED ALTHOUGH THE COAGULATION BUTTON WAS NOT PRESSED WHEN THE DEVICE WAS CONNECTED TO A GENERATOR. THE GENERATOR WAS REPLACED TO ANOTHER ONE, BUT THE SAME EVENT OCCURRED. THE DEVICE WAS NOT USED FOR 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 Consequences Or Impact To Patient

  MAUDE report 9246600 ↗
• MalfunctionJan 9, 2019Self-Activation or Keying

  SUCTIONED WITHOUT PUSHING THE SUCTION BUTTON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232264 ↗
• MalfunctionMar 6, 2018Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLISTER WAS CRACKED. 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 7318434 ↗
• MalfunctionJan 11, 2018Contamination

  IT WAS REPORTED THAT THERE WAS A CONTAMINATION ISSUE. THE PLASTIC PACKAGE WAS OPEN. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183588 ↗
• MalfunctionJan 11, 2018Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THERE WAS A CONTAMINATION ISSUE. THE PLASTIC PACKAGE WAS OPEN. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183568 ↗
• MalfunctionJan 11, 2018Unsealed Device Packaging

  IT WAS REPORTED THAT THERE WAS A CONTAMINATION ISSUE. THE PLASTIC PACKAGE WAS OPEN. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183560 ↗