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	Foreign Body In Patient (2687)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.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.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events.If additional information becomes available, this report will be updated and supplemented accordingly.
Event or Problem Description
Olympus was informed that during a cystoscopy procedure, the doctor located and removed a broken portion of the inner sheath.Reportedly, the device fragment remained in the patient after undergoing a transurethral resection of the prostate (turp) on (b)(6) 2018 or (b)(6) 2018.The doctor was unsure if the patient sustained any injury; however, reported that the patient could¿ve experienced some bleeding.The intended procedure was completed.No further information was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from medwatch report number: (b)(4).The service center received additional from a medwatch which states the patient¿s previous procedure was a cystoscopy for bladder clot evacuation and fulguration of bleeder at the upper bladder neck.A 24-french olympus resectoscope sheath with a 30 degree telescope in a visual obdurate was passed per the long urethra into the erosive fossa and bladder where careful pan endoscopy was carried out.There were multiple blood clots noted in the prostate fossa and filled up the large bladder lumen with clot tamponade.With the tip of the resectoscope sheaths in the bladder lumen, the working element was removed, as the soft tip 16 french suction tube was connected to the neptune suction machine, and intermittent suction was upright through the resectoscope sheath to disintegrate and evacuate the blood clots.

• 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
• MDR Report Key: 8531432
• Report Number: 2951238-2019-00751
• Device Sequence Number: 11242813
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2019

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 139W-0069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 121