Olympus WA94007ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Single Use Plasma Coagulation Probe Radial Argon PA-231U 2.3 x 2200 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761083475), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bowel Burn1
- Bowel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
DURING A THERAPEUTIC COLONOSCOPY PERFORMED FOR RECTAL BLEEDING AND TREATMENT OF A SMALL ANGIODYSPLASIA LESION, THE PHYSICIAN USED A RADIAL ARGON PROBE TO COAGULATE A LESION IN THE CECUM. THE CUSTOMER REPORTED ARGON PROBE MALFUNCTION AND SUBSEQUENT PERFORATION. ADDITIONAL INFORMATION WAS OBTAINED THAT SUPERFICIAL MUCOSAL BURNING WAS OBSERVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED INTENSE PAIN, JERKING, SENSATIONS OF ELECTRIC SHOCK AND CONTRACTIONS OF THE ABDOMEN. POST-PROCEDURE, THE PATIENT COMPLAINED OF POST-OPERATIVE PAIN, AND A DECISION WAS MADE TO TAKE THE PATIENT TO THE OPERATING ROOM FOR FURTHER MANAGEMENT AND INVESTIGATION. AN INTESTINAL BURN WAS NOTED IN THE CECUM, WHICH APPEARED TO CORRESPOND WITH THE SITE OF THE ARGON PROCEDURE. THE INJURY WAS REPAIRED WITH SUTURES AND NO INTESTINAL RESECTION WAS NECESSARY. THE PERFORATION WAS REPORTED TO BE 2 TO 3 CM. THE PATIENT WAS DISCHARGED HOME, AS REPORTED. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE CUSTOMER INITIALLY REPORTED AS AN ARGON PROBE MALFUNCTION, HOWEVER, LATER INDICATED THAT THEY CANNOT CONFIRM THE CAUSE. NO DEVICE ERROR MESSAGES WERE REPORTED, ADDITIONALLY, THE CUSTOMER'S CLINICAL TEAM NOTED TH
Patient problems: Bowel Burn; Bowel Perforation
MAUDE report 24643065 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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