MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A

Model Number	A22040T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.However, based on similar reported events, the most probable cause of the reported event could be attributed to user handling.The instruction manual provides warning which states that " impact, fall, shock or similar stress can damage the ceramic insulation at the sheath's distal end and that the instrument must not be used if damaged since otherwise this can cause injuries to the patient and/or user." in addition, the oem performed a manufacturing and quality control review for the affected lot number without showing any non-conformities or deviations regarding the related issue.If additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that during a transurethral resection of bladder tumor (turbt) procedure, the black tip of the inner sheath broke off and fell inside the patient¿s bladder.The device fragment was retrieved with an unknown device.It is unknown if the intended procedure was completed.There was no patient injury reported.Additionally, the user facility reported that no other equipment was replaced during the procedure, the sheath did not experience any external impact or falls prior to the procedure and was inspected with no anomalies noted.The sheath also had been lubricated prior to assembly with other equipment.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8188045
• Report Number: 2951238-2018-00785
• Device Sequence Number: 19207945
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 156W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR