TIPCONTROL 49936911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207054192), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 malfunction.

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

• MalfunctionFeb 15, 2018Melted; Material Separation

  RICHARD WOLF MEDICAL INSTRUMENT CORPORATION (RWMIC) WAS INFORMED BY FACILITY THAT DURING A PROCEDURE THE INSULATION NEAR TO THE TIP OF THE BIPOLAR DEVICE MELTED AWAY AND SEPARATED. NO INJURY TO PATIENT OR STAFF REPORTED. MANUFACTURING DATE: 28JULY2017, EXPIRATION DATE: 27JULY2020. DEVICE WAS RETURNED TO RWMIC AND WILL BE SENT TO SUPPLIER FOR INVESTIGATION. USER FACILITY WAS CONTACTED VIA EMAIL, IN AN EFFORT TO GATHER ADDITIONAL/MISSING MEDWATCH INFORMATION, NO RESPONSE AS OF 15FEB2018. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVES ADDITIONAL INFORMATION, FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274918 ↗