MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A; RESECTOSCOPE SHEATH

Model Number	A22040T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k931994/ k931995.The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
It was reported that a piece of the ceramic part of the distal tip broke off while during insertion into the patient.The tip was retrieved with no patient injury.Additional information is unavailable at this time.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information (a2, a3, a4, h10) regarding the reported event.Additional information received identified the procedure taking place at the time of the event was an optical internal urethrotomy, direct visual internal urethrotomy.It was also reported the broken tip was retrieved with the grasper [sic].There was no procedural delay and the procedure was completed with a different device.It was noted the device was inspected prior to use and no anomalies were found.The device failed at the start of the procedure.The patient has been discharged home.The patient's weight was reported as 124.693 kg.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s investigation summary.Since the product was not returned to the legal manufacturer, the investigation is based solely on the information provided by the customer.Based on the customer¿s description of the damage at the ceramic tip, the legal manufacturer assumed that it was induced by thermo-mechanical fatigue.The broken fragment and the damaged shaft are not available for investigation.The legal manufacturer cannot determine if the insulation insert was previously damaged or worn, and if the damage occurred during the last preparation (cds) of the instrument or during its last use in a procedure.According to the customer, the broken fragment was retrieved from the patient¿s body.Lost fragments of the ceramic insulation insert can be localized using a suitable x-ray procedure or computed tomography.The risk to patients, users, and/or third parties associated with the reported issue was evaluated as acceptable and no further corrective action is a manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.There are no further countermeasures necessary, because the associated risk is acceptable.The legal manufacturer will continue to monitor the occurrence rate in the context of our quality management system.If necessary, the legal manufacturer will take further action in the future.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10352139
• Report Number: 9610773-2020-00175
• Device Sequence Number: 2603042
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2020

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: A22040T
• Device Catalogue Number: A22040T
• Device Lot Number: 18ZW-0172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/31/2020; 09/25/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/24/2020; 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 125