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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that a part of the ceramic insulation at the distal end of the resection sheath is broken off.However, it cannot be determined with certainty whether the resection sheath had been previously damaged during reprocessing without parts breaking off immediately or whether the damage occurred during the procedure.The cause of this damage is most likely thermal and/or mechanical overload by the application of excessive force like impact, fall, shock or similar stress.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 but, independently from the above mentioned issue, a capa was initiated in (b)(6) 2019 where further investigations, trending, and surveillance will be performed.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
Event or Problem Description
Olympus was informed that after cleaning/reprocessing following an unspecified therapeutic resection procedure at an unknown date, a fragment of ceramic insulation at the distal end of the resection sheath was found to have broken off and is missing.It is unknown whether this happened during the procedure or during reprocessing.No further information was provided and there was no report about an adverse event or patient injury.

• 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 22045 ; GM 22045
• MDR Report Key: 8730343
• Report Number: 9610773-2019-00073
• Device Sequence Number: 19463366
• Product Code: FJL
• UDI-Device Identifier: 04042761020893
• UDI-Public: 04042761020893
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: A22014A
• Device Catalogue Number: A22014A
• Device Lot Number: 17YW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1