MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR., WITH DEFLECTING OBTURATOR; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number	A22042T
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience, the reported phenomenon could not be determined, and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure on (b)(6) 2020, the ceramic insulation at the distal end of the resection sheath broke off inside the patient.However, this went unnoticed until (b)(6) 2020, when a cystoscopy procedure was performed due to the recurrence of the bladder tumor, and a fragment of the beak was noticed inside the patient's prostate.Due to the recurrence of the bladder tumor, a follow-up turbt procedure is scheduled for (b)(6) 2020, during which the broken-off fragment is to be retrieved.There was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation in hinode, japan (omsc), (returned to omsc on 2020-10-06).The evaluation at omsc hinode confirmed that the ceramic insulation at the distal end of the resection sheath is broken off.The cause of this damage is most likely mechanical overload due to the application of excessive force and/or mechanically induced wear and tear.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged before the incident occurred, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the last procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The case will be closed on olympus side and the user will be informed about the investigation results.

• Brand Name: RESECTION SHEATH, 26 FR., WITH DEFLECTING OBTURATOR
• Common Device Name: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10545202
• Report Number: 9610773-2020-00216
• Device Sequence Number: 3546206
• Product Code: FJL
• UDI-Device Identifier: 04042761020992
• UDI-Public: 04042761020992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: A22042T
• Device Catalogue Number: A22042T
• Device Lot Number: 131W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1