MAUDE Adverse Event Report: RICHARD WOLF GMBH; INNER SHEATH RESECTOSCOPE 22FR

Model Number	86753225
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Richard wolf is reporting this event under part 86753225, inner sheath resectoscope 22fr, batch 1593766, as the suspect medical device, because the defective 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 are both components of the inner sheath resectoscope.Components do not have fda product codes and are not required.

• Common Device Name: INNER SHEATH RESECTOSCOPE 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21573201
• Report Number: 1418479-2025-00002
• Device Sequence Number: 8272251
• Product Code: FJL
• UDI-Device Identifier: 04055207065464
• UDI-Public: 04055207065464
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2025
• Report Date (Section F): 03/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 86753225
• Device Catalogue Number: 86753225
• Device Lot Number: 1593766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/12/2025
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/11/2025