ENDOPATH 5DSGRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036000792), received between Nov 2, 2017 and Feb 18, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE DEVICE COULD NOT GRIP THE TISSUE PROBABLY THE ALIGNMENT WAS DISLODGED. 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 21401941 ↗
• InjuryApr 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  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. EVALUATION OF OUTCOMES OF ENDOPATH ENDOSCOPIC HAND INSTRUMENTS. PRESENCE OF AN ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE FOR ACCIDENTAL PUNCTURE OR LACERATION DURING THE INDEX ADMISSION. ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19072204 ↗
• MalfunctionSep 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP ON THE GRASPER HAD BROKEN AND THE SCREW CAME OUT. IT WAS RETRIEVED AND A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689785 ↗
• MalfunctionNov 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON WAS USING THE DEVICE, HE FELT THAT THE RATCHET OF THE DEVICE WAS SHAKING AND FOUND THAT THERE WAS A GAP BETWEEN PLASTICS ON THE JOINT. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815349 ↗
• InjurySep 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNH): INITIAL FINDINGS FROM A KOREAN SURGEON AUTHOR: MYEONG-SEON KIM, JOSEPH J. NOH AND TAE-JOONG KIM CITATION: KIM M-S, NOH JJ AND KIM T-J (2021) HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNH): INITIAL FINDINGS FROM A KOREAN SURGEON. FRONT. MED. 7:583147. DOI: 10.3389/FMED.2020.583147. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE FEASIBILITY AND SAFETY OF HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNOTES). FROM APRIL 2018 TO JUNE 2019, A TOTAL OF 34 FEMALE PATIENTS UNDERWENT VNOTES USING SUCTION AND IRRIGATOR, SHORT GRASPER (ENDOPATH GRASPER 5MM, ETHICON US, LLC), AND ENSEAL G2 TISSUE SEALER (45 CM LENGTH AND CURVED TIP, ETHICON US, LLC). ONE PATIENT UNDERWENT TRANSUMBILICAL SINGLE-PORT SURGERY BECAUSE OF LATE-ONSET POSTOPERATIVE BLEEDING ON THE 13TH POSTOPERATIVE DAY. ALTHOUGH THERE WERE THREE COMPLICATIONS, VNOTES OFFERS ADVANTAGES TO PATIENTS AND SURGEONS. MORE SURGICAL TECHNIQUES WILL BE DEVELOPED IN VNOTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469929 ↗
• MalfunctionJan 11, 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 DAMAGED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13218486 ↗
• MalfunctionNov 12, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A FOREIGN MATTER LIKE A HAIR WAS FOUND IN THE PACKAGE WHEN THE PACKAGE WAS OPENED. 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 8060525 ↗
• MalfunctionNov 2, 2017Device Packaging Compromised

  IT WAS REPORTED THAT, CUT MARK IN THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996071 ↗