NA 86753245Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207065471), received between Oct 29, 2020 and Mar 13, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE INFORMATION RECEIVED, THE COATING MATERIAL OF THE O-RINGS, O-RING 7,65X 1,78 VMQ-70 COATED, PART 15364395, BATCH 4500409934, AND O-RING 9,25X 1,78-VMQ-70 COATED, PART 15364396, BATCH 59037/1, WERE FOUND TO BE PEELING OFF AFTER STERILIZATION OF THE RESECTOSCOPE. THE O-RINGS ARE USED IN INNER SHEATH RESECTOSCOPE 24FR, PART 86753245, BATCH 1587669.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595906 ↗
• InjuryMar 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AT THE BEGINNING OF A HOLEP PROCEDURE, THE COATING MATERIAL OF THE O-RINGS, PART 15364395, BATCH 4500409934, AND PART 15364396, BATCH 59037/1, ON THE INNER SHEATH RESECTOSCOPE, PART 86753245 BATCH 1587669, WERE FOUND TO BE PEELING OFF. THERE WAS A REPORTED HOUR DELAY WHILE THE SURGICAL STAFF TRIED TO CLEAN UP THE O-RINGS. THERE WERE NO OTHER BACK-UP RESECTOSCOPE AVAILABLE, AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575843 ↗
• InjuryMar 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AT THE BEGINNING OF A HOLEP PROCEDURE, THE COATING MATERIAL OF THE O-RINGS, PART 15364395, BATCH 4500409934, AND PART 15364396, BATCH 59037/1, ON THE INNER SHEATH RESECTOSCOPE, PART 86753245 BATCH 1587669, WERE FOUND TO BE PEELING OFF. THERE WAS A REPORTED HOUR DELAY WHILE THE SURGICAL STAFF TRIED TO CLEAN UP THE O-RINGS. THERE WERE NO OTHER BACK-UP RESECTOSCOPE AVAILABLE, AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575685 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  RICHARD WOLF RECEIVED A MEDSUN/MEDWATCH REPORT FROM THE FDA: THE DESCRIPTION EVENT OR PROBLEM: MIDWAY THROUGH THE TURBT (TRANS URETHRAL RESECTION OF BLADDER TUMOR) THE DOCTOR NOTICED THERE WAS A PIECE MISSING FROM THE END OF THE 26 FRENCH SHEATH FROM THE WOLF TUR KIT. IT IS UNKNOWN WHETHER THE SHEATH WAS DAMAGED PRIOR TO THE START OF THE CASE OR IF THE PIECE CHIPPED OFF DURING THE CASE. SEVERAL X-RAYS WERE TAKEN BY THE DOCTOR IN OR 17, NONE OF WHICH REVEALED A VISIBLE PIECE IN THE PATIENT. THE PATIENT WAS INTERNALLY EXAMINED USING A CYSTOSCOPE AND AGAIN NO PIECES WERE NOTICED TO BE LEFT IN THE PATIENT. ADDITIONAL INFORMATION" WILL THE DEVICE BE RETURNED? ACCORDING TO THE MEDWATCH REPOR INITIATOR, THE DEVICE WAS RETURNED ON 3 MAY 2021. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? NONE WAS REPORTED IN THE MEDWATCH REPORT. DID THE DELAY PUT THE PATIENT AT RISK? NONE WAS REPORTED IN THE MEDWATCH REPORT. WAS THERE A SIMILAR BACK-UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548593 ↗
• MalfunctionOct 29, 2020Break; Temperature Problem; Break; Temperature Problem

  THE PURPOSE OF THIS REPORTS IS TO SHARE THE RESULTS OF THE DEVICE INVESTIGATION/EVALUATION. THE DEVICE WAS RECEIVED AND VISUALLY INSPECTED. THE REPORTED CONDITION - LOOPS WERE COMPLETELY BURNING - WAS CONFIRMED DURING EVALUATION. THE PROBABLE ROOT CAUSE WAS THOUGHT TO BE USER ERROR. THE MANFACTURER REPORTS THE FOLLOWING FINDINGS: AFTER CONSULTATION WITH THE USER, IT WAS DETERMINED THAT THE ELECTRODES WERE USED WITH A MEDTRONIC GENERATOR. THIS CAUSED THE USER TO USE 3-4 ELECTRODES PER TURP. THE GENERATOR WAS REPLACED AND IT WAS DETERMINED THAT THE MEDTRONIC GENERATOR WAS CAUSING THE LOOPS TO BURN OUT COMPLETELY. ACCORDING TO THE SUPPLEMENT BB-D366, SYSTEM OVERVIEW "SHARK" RESECTOSCOPES, THE SYSTEM COMPONENTS LISTED IN THE TABLES MUST ONLY BE USED IN COMPLIANCE WITH THE GA-D366 INSTRUCTION FOR USE. IN GENERAL, THE USER IS ADVIED IN THE CORRESPONDING INSTRUCTIONS FOR USE GA-D366/EN/2018-03 V5.0/PK 18-9297 UNDER CHAPTER 8 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE EACH USE. DO NOT USE PRODUCTS THAT ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. POSSIBLE DAMAGE OR DEVIATIONS CAN BE EASILY DETECTED BY HOSPITAL PERSONNEL. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756228 ↗