MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR; SCOPE

Model Number	A22041T
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was notified of the event from the customer via mw5107602.During a cystoscopy transurethral resection of the prostate, the tip of the swivel obturator on the scope broke off in the patient.The broken tip was retrieved and no pieces were left in the patient.It is unknown if the device was inspected prior to the procedure.The customer reported this malfunction occurred at the end of the procedure and the procedure was successfully completed.There was no procedural delay, no change in the patient's treatment course due to the malfunction and no post-operative issues with the patient due to this issue.The customer requested a re-education on the proper handling of this device and there have not been any further issues since training.

• Brand Name: RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR
• Common Device Name: SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 14190477
• Report Number: 2951238-2022-00389
• Device Sequence Number: 14571368
• Product Code: HIH
• UDI-Device Identifier: 04042761020978
• UDI-Public: 04042761020978
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/22/2022
• Report Date (Section F): 03/25/2022

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: A22041T
• Device Catalogue Number: A22041T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2022
• 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