Olympus A0358Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04042761001557), received between Nov 17, 2021 and May 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Failure to Conduct; Failure to Conduct

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED COMPONENT FAILURE OF THE HF-CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048823 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED, THE MONOPOLAR HIGH FREQUENCY CABLE WAS BROKEN. THE USER WAS IMAGING INSIDE THE PATIENT AND THE CAUTERY SCREEN GAVE A CABLE WARNING. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740759 ↗
• MalfunctionDec 1, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, A PIECE OF METAL HF-CABLE, MONOPOLAR HAD FALLEN ON THE MACHINE TABLE DURING THE SURGERY. IT WAS SUSPECTED THAT THE COATING INSIDE AND AT THE CONTACT POINT WITH THE FORCEPS MAY HAVE PEELED OFF. THE TECHNIQUE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249470 ↗
• MalfunctionNov 28, 2023Break; Electrical Shorting; Break; Electrical Shorting

  THE CUSTOMER INITIALLY REPORTED TO OLYMPUS THAT WHEN CUTTING THE GALLBLADDER OF THE PATIENT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AN ELECTRIC KNIFE WAS USED TO PERFORM ELECTROCOAGULATION FOR HEMOSTASIS, AND A SUDDEN ELECTRICAL CONDUCTIVITY AT THE ELECTROCOAGULATION WIRE HANDLE LED TO THE SURGEON'S GLOVE BREAKAGE, CAUSING A BURN OF APPROXIMATELY 0.5X0.3 MM ON THE OPERATOR'S RIGHT THUMB. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS THEN RECEIVED FURTHER INFORMATION CLARIFYING THAT THE HIGH-FREQUENCY CABLE (A0358) WAS DAMAGED, AND THE SURGEON TOUCHED THE DAMAGED AREA WITH THEIR HANDS DURING USE, RESULTING IN BURNS. THERE WAS NO MALFUNCTION OF THE ESG-400 THAT WAS ALSO USED IN THE PROCEDURE. THE CUSTOMER FURTHER CLARIFIED THAT THE SURGEON SUSTAINED A THIRD DEGREE BURN WITH A SMALL AREA OF 2X5 MM TREATED WITH COLD APPLICATION. THERE WERE NO OTHER SYMPTOMS OR COMPLICATIONS. THE SURGEON CURRENTLY DOES NOT REPORT ANY DISCOMFORT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18219819 ↗
• MalfunctionOct 31, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE HAD A BROKEN LIGHT POST. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040016 ↗
• MalfunctionFeb 13, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  OLYMPUS (OCI) WAS INFORMED BY THE NURSE AT THE USER FACILITY, THE CUSTOMER HIGH-FREQUENCY MONOPOLAR CABLE MALFUNCTIONED, ¿THE CABLE STARTED TO HUM (AUDITORY) AND THEN BECAME RED AND SNAPPED IN TWO.¿ THE CUSTOMER REPORTED EVENT WAS FOUND DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. ANOTHER CABLE WAS USED TO COMPLETE THE INTENDED PROCEDURE. NO OTHER EQUIPMENT WAS REPLACED AND NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368038 ↗
• MalfunctionAug 25, 2022Sparking; Output Problem; Temperature Problem; Sparking; Output Problem; Temperature Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC LAPAROSCOPIC SURGERY, THE AREA NEAR THE CONNECTION BETWEEN THE HF-CABLE AND THE HF-ELECTRODE POPPED AND A SPARK OCCURRED. BEFORE THIS HAPPENED THE SURGEON HAD FELT THE HANDLE OF THE HF-ELECTRODE TO BE HOT AND THE OUTPUT PERFORMANCE OF THE ELECTRODE TO BE WEAKER THAN NORMAL. THE SURGEON THEN REPLACED BOTH THE HF ELECTRODE AND THE HF-CABLE. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292496 ↗
• MalfunctionMay 20, 2022Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE HF CABLE BROKE. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460678 ↗
• MalfunctionDec 6, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  THE OLYMPUS TERRITORY SALES MANAGER WAS INFORMED BY THE STERILE PROCESSING MANAGER AT THE USER FACILITY THAT THE HIGH FREQUENCY MONOPOLAR CABLE REPORTEDLY ¿EXPLODED, WITH A SMALL FLAME¿ DURING AN UNSPECIFIED EVENT. THERE WAS NO INJURY OR HARM REPORTED. NO DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935044 ↗
• MalfunctionNov 17, 2021Break; Mechanical Problem; Break; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC APPENDIX REMOVAL PROCEDURE, THE HF-CABLE BROKE AND MADE AN EXPLOSION SOUND. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR CABLE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12826430 ↗