n.a. UF902Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551372203), received between Jan 23, 2025 and Apr 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Excessive Heating” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT INSUFFICIENT MONOPOLAR CAUTERY. PATIENT INVOLVED. PATIENT WAS INJURED; CUSTOMER HAD TO GET A BLOOD TRANSFUSION. PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH THE 5MM ROLLER-BALL MONOPOLAR ELECTRODE AND INSUFFICIENT CAUTERY CAUSED EXCESSIVE BLEEDING. COAGULATION WAS MAXED AT 120 WATTS. PATIENT HAD TO HAVE BLOOD TRANSFUSED. CROSS REFERENCE UF/IMPORTER REPORT # 2020550-2025-00638.

  Patient problems: Insufficient Information

  MAUDE report 21873797 ↗
• InjuryApr 21, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT INSUFFICIENT MONOPOLAR CAUTERY. PATIENT INVOLVED. PATIENT WAS INJURED; CUSTOMER HAD TO GET A BLOOD TRANSFUSION. PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH THE 5MM ROLLER-BALL MONOPOLAR ELECTRODE AND INSUFFICIENT CAUTERY CAUSED EXCESSIVE BLEEDING. COAGULATION WAS MAXED AT 120 WATTS. PATIENT HAD TO HAVE BLOOD TRANSFUSED. CROSS REFERENCE MFR REPORT # 1221826-2025-00638.

  Patient problems: Insufficient Information

  MAUDE report 21873781 ↗
• InjuryJan 23, 2025Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00050, 9610617-2025-00051, 9610617-2025-00052, 9610617-2025-00053 AND 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222411 ↗
• InjuryJan 23, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00050, 9610617-2025-00051, 9610617-2025-00052, 9610617-2025-00053, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222363 ↗