SHARK/S-LINE 46221313USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207066027), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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.

• MalfunctionOct 3, 2024Melted; Overheating of Device; Melted; Overheating of Device

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A MEDSUN REPORT: (B)(4), REGARDING AN ISSUE WITH A CUTTING ELECTRODE BIPO 24FR 12/30°, PART ID: 46221313US, LOT# 51018536. ACCORDING TO THE MEDSUN REPORT, "PROVIDER NOTED ISSUES WITH FOOT PEDAL FOR ERBE NOT CHARGING ELECTRODE, THEN WOULD HEAT SUDDENLY. THE TECH NOTED THAT ELEMENT BURNED "WHITE HOT". WHEN THE LENS CRACKED, SCOPE SET UP WAS REMOVED. THE TECH NEEDED A KELLY CLAMP TO UNSEAT ELECTRODE FROM RESECTOSCOPE. PATIENT EXPERIENCED AGGRESSIVE BILATERAL LEG MOVEMENTS DURING LOOP CAUTERY, REQUIRING MORE SEDATION. TECH NOTED WHAT APPEARED TO BE METAL FLUSH OUT OF PATIENT DURING PROCEDURE AND ASKED PROVIDER; PROVIDER BELIEVED IT MAY HAVE BEEN FROM UROCLIPS THAT WERE BEING REMOVED DURING PROCEDURE. ONCE REMOVED, UROCLIPS APPEARED TO BE COMPLETELY INTACT." ORIGINAL INTENDED PROCEDURE: CYSTOSCOPY WITH TRANSURETHRAL PROSTATECTOMY, CYSTOSCOPY LITHOLAPAXY.

  Patient problems: Insufficient Information

  MAUDE report 20358712 ↗