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

Model Number	WA22017A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during the procedure, the ceramic tip on the inner sheath broke off in the patient.The patient was large with a very large prostate and elevated bladder neck.Visibility was poor due to bleeding.The doctor was putting a lot of torque on the scope and the sheath and damaged the sheath in the process.When the sheath was removed, it was noticed it was broken.The doctor was informed that the piece needed to be retrieved, and he stated he could not at that time and he would retrieve it when the patient came back for the robot prostate.A catheter was inserted and the case was aborted.

• Brand Name: INNER SHEATH, LONG, FOR WA22018A AND WA22019A
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 17484472
• Report Number: 2429304-2023-00252
• Device Sequence Number: 7260598
• Product Code: FJL
• UDI-Device Identifier: 04042761051514
• UDI-Public: 04042761051514
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2023
• Report Date (Section F): 07/10/2023

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2023
• 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: Required Intervention
• Patient Sex: Male