Olympus WA94002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14042761083420), received between Apr 24, 2023 and Sep 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024No Device Output; No Device Output

  IT WAS REPORTED, THE PLASMA COAGULATION PROBE OUTPUT DID NOT START WHEN ATTEMPTING TO STOP BLEEDING. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO THE SAME PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236966 ↗
• InjuryApr 24, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ATTEMPT TO COAGULATE AN ANGIODYSPLASIA IN THE COECUM USING THIS SINGLE USE PLASMA COAGULATION PROBE, THE PATIENT'S MUSCLES CONTRACTED WHEN THE FOOT SWITCH WAS ACTUATED. THE ARGON PROBE DID NOT IGNITE, AND NO COAGULATION WAS ACHIEVED ON THE SITE. THEN A CHANGE WAS MADE TO A NEW PROBE, AND THE SAME PROBLEMS OCCURRED AT THE SAME SPOT. IT WAS ONLY WHEN A SPOT ABOUT 5 CM AWAY FROM THE ORIGINAL SPOT WAS ACCESSED THAT IGNITION AND COAGULATION OCCURRED. IN THE EVENING, THE PATIENT WAS THEN FOUND TO HAVE A PERFORATION IN THE COECUM AT THE FIRST LOCATION. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD TO BE OPERATED BECAUSE OF THE PERFORATION BUT IS NOW SYMPTOM-FREE. THE PROBE WAS CHECKED FOR INTACTNESS AND RINSED 2 TIMES BEFORE THE EXAMINATION. NO ABNORMALITIES WERE FOUND. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) 1ST OF 2 PROBES USED. (B)(6) 2ND OF 2 PROBES USED. THIS REPORT IS FOR (B)(6).

  Patient problems: Bowel Perforation

  MAUDE report 16802846 ↗
• InjuryApr 24, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ATTEMPT TO COAGULATE AN ANGIODYSPLASIA IN THE COECUM USING THIS SINGLE USE PLASMA COAGULATION PROBE, THE PATIENT'S MUSCLES CONTRACTED WHEN THE FOOT SWITCH WAS ACTUATED. THE ARGON PROBE DID NOT IGNITE, AND NO COAGULATION WAS ACHIEVED ON THE SITE. THEN A CHANGE WAS MADE TO A NEW PROBE, AND THE SAME PROBLEMS OCCURRED AT THE SAME SPOT. IT WAS ONLY WHEN A SPOT ABOUT 5 CM AWAY FROM THE ORIGINAL SPOT WAS ACCESSED THAT IGNITION AND COAGULATION OCCURRED. IN THE EVENING, THE PATIENT WAS THEN FOUND TO HAVE A PERFORATION IN THE COECUM AT THE FIRST LOCATION. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD TO BE OPERATED BECAUSE OF THE PERFORATION BUT IS NOW SYMPTOM-FREE. THE PROBE WAS CHECKED FOR INTACTNESS AND RINSED 2 TIMES BEFORE THE EXAMINATION. NO ABNORMALITIES WERE FOUND. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) 1ST OF 2 PROBES USED. (B)(6) 2ND OF 2 PROBES USED. THIS REPORT IS FOR (B)(6).

  Patient problems: Bowel Perforation

  MAUDE report 16802656 ↗