MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTO-URETHROSCOPY SHEATH, 22FR; RIGID ENDOSCOPE SHEATH

Model Number	27026B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is awaiting receipt of the device for investigation.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): during the surgery the tip of cystoscope fractured and could not be removed.No injury; however the tip could not be retrieved during the procedure.The patient underwent subsequent minor surgery and the cystoscope tip was retrieved from the bladder without any concern.
Additional Manufacturer Narrative
During the surgery the tip of cystoscope fractured and could not be removed.No injury - however the tip could not be retrieved during the procedure.The patient underwent subsequent minor surgery and the cystoscope tip was retrieved from the bladder without any concern.
Additional Manufacturer Narrative
Investigation conclusion: the device in question was sent to the manufacturing site in germany on 17th november 2020 for investigation upon evaluation, it could be confirmed that the device was not in original shape, and the distal tip was missing.The shaft was found to be bent, deflection of approx.3 mm.Also, there were signs of corrosion on the broken area as well as on other parts of device.The device was manufactured on 07.2007.The root cause most probably is too high force application which results in breakage on the tip.Warning of not overload the device by exerting too much force was already included in ifu.

• Brand Name: CYSTO-URETHROSCOPY SHEATH, 22FR
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10713006
• Report Number: 9610617-2020-00114
• Device Sequence Number: 14282388
• Product Code: ODB
• UDI-Device Identifier: 04048551050460
• UDI-Public: 4048551050460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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: 27026B
• Device Catalogue Number: 27026B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 12/11/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 08/08/2022; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown