Kirwan 30-5200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841019107393), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2020Defective Device; Sparking

  PRIOR TO COMMENCEMENT OF THE ADENOIDECTOMY, A MOIST GAUZE WAS PLACED OVER THE LIP AND INTRAORAL MUCOSA FOR PROTECTION. THE ADENOIDS WERE IDENTIFIED AND WERE ABLATED WITH THE SUCTION CAUTERY DEVICE IN THE STANDARD FASHION. TOWARD THE COMPLETION OF THE PROCEDURE, THE SURGEON NOTED A SPARK EMANATE AT THE LEVEL OF THE LIP. AT THIS POINT, THE SUCTION CAUTERY WAS STILL PROTECTED FROM THE LIP WITH THE MOIST GAUZE, THE SURGEON CEASED CAUTERY AND REMOVED THE SUCTION CAUTERY DEVICE TO REVEAL A BURN ON THE LOWER LIP AND MUCOSA AS WELL AS SKIN. INSPECTION OF THE SUCTION CAUTERY DEVICE INDICATE A DEFECT IN THE PROTECTIVE INSULATION IN THE CAUTERY AT APPROX THE SAME LOCATION WHERE THE SPARK WOULD HAVE OCCURRED. EQUIPMENT SEQUESTERED AND ALL SAME LOT NUMBER HAND PIECES REMOVED FROM INVENTORY. (B)(4) MODEL FT10 S/N (B)(4) WHICH IS ONLY 6 MONTHS OLD WAS INSPECTED WITH NO PROBLEMS FOUND. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Burn(s)

  MAUDE report 9840404 ↗