SHARK 8676424Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207019740), received between Aug 10, 2021 and Dec 4, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 4, 2023Material Fragmentation; Material Fragmentation

  THE USER FACILITY HAS INFORMED RICHARD MEDICAL INSTRUMENTS CORP. (RWMIC) OF AN ISSUE REGARDING A SHEATH RESECTOSCOPE 24FR, PART ID: 8676424, LOT # 1497661. ACCORDING TO THE RECEIVED INFORMATION," BEAK OF THE SHAFT END IS BROKEN. WHEN THE SCOPE AND SHEATH WERE IN THE BLADDER, A BLACK PIECE OF MATERIAL WAS SEEN AND REMOVED. ONCE REMOVED WE REALIZED IT WAS PART OF THE SHEATH. WE LOOKED AT THE SHEATH AND SAW THAT IT WAS BROKEN." THERE IS NO REPORT OF INJUIY TO THE PATIENT OR OTHER PERSONNEL AS A RESULT OF THE REPORTED ISSUE. HOWEVER, THE REPORTED ISSUE CAUSED A SHORT DELAY DURING THE BEGINNING OF A TRANSURETHRAL RESECTION BLADDER TUMOR PROCEDURE WHILE THE BACK-UP DEVICE WAS RETRIEVED TO COMPLETE THE SCHEDULED PROCEDURE. THERE WAS NO ADDITIONAL TREATMENT OR PROCEDURE NEEDED. THE COMPLAINANT CONFIRMED THERE WAS NO RISK TO THE PATIENT AS THE TIP WAS SUCCESSFULLY RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 18260528 ↗
• InjuryNov 16, 2023Material Fragmentation; Material Fragmentation

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A SHEATH RESECTOSCOPE 24FR, PART ID: 8676424, BATCH# 1433702. THE USER REPORTED THAT AT THE END OF THE OPERATION, AN IMMEDIATE FOLLOW-UP CHECK OF THE EQUIPMENT REVEALED THAT THE TIP OF THE RESECTOSCOPE SHAFT WAS MISSING. AFTER A BRIEF X-RAY CHECK, THE TIP WAS FOUND LYING IN THE BLADDER AND THE BROKEN PART WAS REMOVED USING A CYSTOSCOPE AND GRASPING FORCEPS. THERE WERE NO FURTHER COMPLICATIONS FOR THE PATIENT. ADDITIONAL UNSCHEDULED MEASURES HAD TO BE TAKEN, NAMELY X-RAY CONTROL AND REMOVAL OF THE RESECTOSCOPE TIP. THESE MEASURES LED TO A DELAY IN SURGERY OF 25 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18147785 ↗
• InjuryAug 18, 2021Material Fragmentation; Material Fragmentation

  PLEASE SEE MANUFACTURERS NARRATIVE FOR THE RESULTS OF THE DEVICE INVESTIGATION.

  Patient problems: Abdominal Pain; Unspecified Gastrointestinal Problem

  MAUDE report 12337665 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION AND FOLLOW-UP COMMUNICATION WITH THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302373 ↗