Medline ReNewal REP104845CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277382640), received between Nov 8, 2016 and Nov 8, 2016 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDLINE RENEWAL RECEIVED A REPORT THAT A REPROCESSED ENT ABLATION WAND WAS SMOKING DURING USE. THE USER WAS REQUIRED TO REPLACE THE DEVICE FOR A NEW ONE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088138 ↗
• MalfunctionNov 8, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDLINE RENEWAL RECEIVED A REPORT THAT REPROCESSED ENT COBLATORS WERE "SMOKING" IN THE OPERATING ROOM, AND THAT THE USERS RAN WATER THROUGH THE DEVICES IN ORDER TO STOP THE DEVICES FROM SMOKING. THE REPORT STATED THAT NO PATIENTS WERE HARMED IN ANY WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088132 ↗