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	Device Embedded In Tissue or Plaque (3165)
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 resection procedure at an unknown date, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient¿s bladder.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 returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the ceramic insulation at the distal end of the resection sheath is broken off and is missing.The type of damage found is typically caused by thermal and/or mechanical overload, possibly as a result of improper reprocessing and/or excessive force.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert was pre-damaged at some point in the past, whether the damage was caused during the reprocessing cycle preceding the incident, or during the last procedure.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Instead a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side but, independently from the above mentioned issue, a capa was initiated in march 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.

• 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: 9271276
• Report Number: 9610773-2019-00154
• Device Sequence Number: 1573041
• 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,Followup
• Report Date (Section B): 11/15/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1