Olympus WA64360CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761068611), received between Aug 25, 2023 and Aug 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that the reusable Rigid endoscopic tissue manipulation forceps exhibited the tip is coming off. The malfunction was identified during reprocessing. There were no reports of patient inolvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477209 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED DURING A LAPAROSCOPIC COLECYSTECTOMY THERAPEUTIC PROCEDURE, A BURN-RELATED DAMAGE OCCURRED ON THE INSULATION SECTION AT THE TIP OF THE JAWS. THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT CONTINUOUSLY. THERE WERE NO DELAYS IN THE PROCEDURE TIME. THERE WERE NO SERIOUS INJURIES OR ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093944 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED DURING A LAPAROSCOPIC COLECYSTECTOMY THERAPEUTIC PROCEDURE, A BURN-RELATED DAMAGE OCCURRED ON THE INSULATION SECTION AT THE TIP OF THE JAWS. THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT CONTINUOUSLY. THERE WERE NO DELAYS IN THE PROCEDURE TIME. THERE WERE NO SERIOUS INJURIES OR ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093927 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HAND INSTRUMENT JAW EXHIBITED THE WELDING OF THE CLAMP CORE WAS LOOSE AND DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859837 ↗
• MalfunctionFeb 27, 2024Loose or Intermittent Connection; Output Problem; Loose or Intermittent Connection; Output Problem

  IT WAS REPORTED, THE ROOT OF THE JAWS WAS LOOSE, AND SPARKS APPEARED WHEN OUTPUT. THE CASE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788600 ↗
• MalfunctionFeb 20, 2024Break; Break

  IT WAS REPORTED, THE FORCEPS DISTAL END WAS CRACKED/CHIPPED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741186 ↗
• MalfunctionAug 25, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT WHEN USING A JAWS "HIQ+", BIPOLAR, 5 X 330 MM, DISSECTION FORCEPS, THE FORCEPS WAS BROKEN, AND THE INSULATION WAS INCOMPLETE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE THERAPEUTIC LAPAROSCOPIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY, OR NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625027 ↗