McKesson 22-ESRSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479209227), received between Nov 25, 2020 and Jan 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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. 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.

• InjuryJan 4, 2023Device Handling Problem; Device Handling Problem

  THE CUSTOMER ALLEGED THE PATIENT RECEIVED A SIGNIFICANT BURN UNDERNEATH A BOVIE PAD.

  Patient problems: Burn(s)

  MAUDE report 16099370 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ALLEGED THAT AFTER THE PROCEDURE WAS COMPLETED AND THE GROUNDING PAD WAS REMOVED, IT WAS NOTED THAT THE PATIENT'S SKIN WAS BURNED ON THE RIGHT THIGH IN TWO AREAS. IT WAS DETERMINED THAT THE PATIENT HAD ACQUIRED SECOND AND THIRD DEGREE BURNS. THE BURNS HAVE REQUIRED MULTIPLE SURGERIES SINCE AND THE PATIENT WAS ADDITIONALLY HOSPITALIZED AS A RESULT.

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 11251197 ↗
• MalfunctionNov 25, 2020Thermal Decomposition of Device; Sparking

  THE CUSTOMER ALLEGED THAT WHILE USING A BOVIE A1250S GENERATOR AND A SOLID DISPOSABLE RETURN PAD, THE GROUNDING PAD BEGAN TO SPARK AND BURN ABOUT AN HOUR INTO THE PROCEDURE. UPON CHECKING GROUNDING PAD, IT WAS NOTED THAT THE CUSTOMER HAD SUSTAINED A FULL-THICKNESS BURN TO HER LOWER EXTREMITY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 10907069 ↗