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

Model Number	A22041T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
Event or Problem Description
The sales representative was informed by the user facility that the resection (inner) sheath tip reportedly broke off in the patient's urethra during an unspecified procedure.It was reported that the doctor pushed back in bladder and used a basket to pull out the broken tip.No death or serious injury was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and the described damage pattern, it is likely the insulation tip's damage was caused by thermal mechanical overload, mechanical impact like fall, shock or similar stress.The instructions for use include a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information and to update the following sections: b5, g3, g6, h2, h6 and h10.
Event or Problem Description
The territory sales manager obtained additional information from the physician who reported the event was observed at the end of a transurethral resection of a bladder tumor procedure.The procedure was prolonged by 15 minutes.As a single piece fell off inside the patient and was retrieved using a cystoscope and a basket.The patient was inspected and confirmed no injury.

• Brand Name: RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR
• Common Device Name: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12397234
• Report Number: 9610773-2021-00244
• Device Sequence Number: 11678001
• Product Code: HIH
• UDI-Device Identifier: 04042761020978
• UDI-Public: 04042761020978
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22041T
• Device Catalogue Number: A22041T
• Device Lot Number: 63W0044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 09/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/03/2021; 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1