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

Model Number	A22014A
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	06/07/2018
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 an unspecified cystoscopy procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation.The evaluation confirmed that the ceramic insulation at the distal end of the resection sheath was broken off.The cause of this damage is most likely mechanical overload as the result of the application of excessive force.Therefore, this event/incident was attributed to use error.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.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., INTERMITTENT IRRIGATION
• Common Device Name: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7624079
• Report Number: 9610773-2018-00059
• Device Sequence Number: 11092142
• Product Code: FJL
• UDI-Device Identifier: 04042761020893
• UDI-Public: 04042761020893
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: A22014A
• Device Catalogue Number: A22014A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1