NA 86753225Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04055207065464), received between Aug 27, 2021 and Mar 13, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 8 most recent of 8 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 22FR, PART 86753225, BATCH 1593766.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595779 ↗
• 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 86753225 BATCH 1593766, WERE FOUND TO BE PEELING OFF. A SECOND INNER SHEATH RESECTOSCOPE, PART 86753245 BATCH 1587669, CONTAINING THE SAME O-RING BATCHES AS THE FIRST RESECTOSCOPE, WAS OPENED AND THE SAME REPEATED ISSUE WAS FOUND. 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 21573321 ↗
• 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 86753225 BATCH 1593766, WERE FOUND TO BE PEELING OFF. A SECOND INNER SHEATH RESECTOSCOPE, PART 86753245 BATCH 1587669, CONTAINING THE SAME O-RING BATCHES AS THE FIRST RESECTOSCOPE, WAS OPENED AND THE SAME REPEATED ISSUE WAS FOUND. 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 21573201 ↗
• MalfunctionAug 25, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE THAT PRODUCT ID# 86753225 LOT 1498308 SHEATH HAS A BROKEN BEAK. THE BEAK BROKE OFF INSIDE PATIENT. ALL PIECES WERE RETRIEVED. INITIAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED AUGUST 5, 2022) "A PERSON JUST BROUGHT ME THE 86753225 LOT 1498308 SHEATH WITH THE BROKEN BEAK. HE REPORTED THE PIECE BROKE OFF INSIDE THE PATIENT. IT WAS RETRIEVED AND IS IN THE PACKAGE WITH THE BROKEN SHEATH." WILL THE DEVICE BE RETURNED? YES. 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? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ON 22-AUG- 2022, ADDITIONAL INFORMATION'S WERE PROVIDED BY THE INITIAL REPORTER: HOW LONG WAS THE PROCEDURE DELAYED? 10 MIN. WHAT ACTIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294807 ↗
• InjuryAug 25, 2022Material Fragmentation; Material Fragmentation

  (B)(4) REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2022, IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A USER FACILITY REPRESENTATIVE THAT PRODUCT ID# 86753225 LOT 1498308 SHEATH HAS A BROKEN BEAK. THE BEAK BROKE OFF INSIDE PATIENT. ALL PIECES WERE RETRIEVED. INITIAL INFORMATION REPORTED BY THE USER FACILITY REPRESENTATIVE: (EMAIL, DATED (B)(6) 2022) "A PERSON JUST BROUGHT ME THE 86753225 LOT 1498308 SHEATH WITH THE BROKEN BEAK. HE REPORTED THE PIECE BROKE OFF INSIDE THE PATIENT. IT WAS RETRIEVED AND IS IN THE PACKAGE WITH THE BROKEN SHEATH." WILL THE DEVICE BE RETURNED? YES. 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? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. ON 22-AUG- 2022, ADDITIONAL INFORMATION'S WERE PROVIDED BY THE INITIAL REPORTER: I. HOW LONG WAS THE PROCEDURE DELAYED? 10 MIN. 2. WHAT ACTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294731 ↗
• MalfunctionJul 21, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT NO. (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY THE SALES REP/USER FACILITY THAT "THE CERAMIC TIP CAME OFF IN A PATIENT DURING A PROCEDURE AND WAS INADVERTENTLY LEFT IN THE PATIENT. THE PATIENT RETURNED TWO DAYS LATER TO HAVE IT REMOVED." ADDITIONAL INFORMATION REPORTED BY THE SALES REPRESENTATIVE (B)(6) 2022: WILL THE DEVICE BE RETURNED? YES. 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? NO. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. RWMIC MDR AWARENESS DATE: (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15076045 ↗
• InjuryJul 21, 2022Break; Material Fragmentation; Break; Material Fragmentation

  RWMIC REFERENCE COMPLAINT NO. (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY THE SALES REP/USER FACILITY THAT "THE CERAMIC TIP CAME OFF IN A PATIENT DURING A PROCEDURE AND WAS INADVERTENTLY LEFT IN THE PATIENT. THE PATIENT RETURNED TWO DAYS LATER TO HAVE IT REMOVED." ADDITIONAL INFORMATION REPORTED BY THE SALES REPRESENTATIVE (7/11/2022): WILL THE DEVICE BE RETURNED? YES. 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? NO. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. RWMIC MDR AWARENESS DATE: 11-JULY-2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15076027 ↗
• MalfunctionAug 27, 2021Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO RICHARD WOLF BY THE USER FACILITY THAT: "TIP BROKE OFF DURING PROCEDURE CAUSING BLEEDING TO THE PATIENT. THIS HAPPENED ON (B)(6) 2021. FACILITY HAS THE SHEATH TO DO A RISK MANAGEMENT ASSESSMENT OF THE ITEM." OTHER SUPPLIED INFORMATION: WILL THE DEVICE BE RETURNED? YES. 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? YES. 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? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? UNKNOWN. THE LOT NUMBER OF THE DEVICE IS UNKNOWN AT THIS TIME..

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12377960 ↗