MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, LONG, FOR WA22018A AND WA22019A; WA22017A

Model Number	WA22017A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
During a transurethral resection of bladder tumor, a piece of the inner sheath broke off in the bladder.The sheath was removed and exchanged, then the physician utilized a grasper to pull out the broken sheath.There was no trauma noted in the bladder or the urethra during extraction.

• Brand Name: INNER SHEATH, LONG, FOR WA22018A AND WA22019A
• Common Device Name: WA22017A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 22341297
• Report Number: 2429304-2025-00191
• Device Sequence Number: 21081293
• Product Code: HIH
• UDI-Device Identifier: 04042761051514
• UDI-Public: 04042761051514
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025
• Report Date (Section F): 06/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22017A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 06/26/2025