MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR., WITH DEFLECTING OBTURATOR; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number	A22041T
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
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 and 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 (tur) procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell into the patient¿s bladder.The fragment was reduced to small pieces using a laser and retrieved afterwards.The intended procedure was successfully completed with a similar device and 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 but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-02-07).The investigation confirmed that the ceramic insulation at the distal end of the resection sheath had broken off.Furthermore, there is a trace of melting inside the resection sheath.The cause of this damage and the breakage of the ceramic insulation is most likely thermal overload (e.G.Excessive high-frequency output power or laser irradiation).Therefore, this event/incident was attributed to use error.Furthermore, 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 from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: RESECTION SHEATH, 24 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
• MDR Report Key: 8251871
• Report Number: 9610773-2019-00043
• Device Sequence Number: 16675363
• Product Code: FJL
• UDI-Device Identifier: 04042761020978
• UDI-Public: 04042761020978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: A22041T
• Device Catalogue Number: A22041T
• Device Lot Number: 148W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1