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

Model Number 27026B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is awaiting receipt of the device for investigation.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 213904296
• Report Number: 9610617-2020-00114
• Device Sequence Number: 1
• Product Code: ODB
• UDI-Device Identifier: 04048551050460
• UDI-Public: 4048551050460
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 27026B
• Device Catalogue Number: 27026B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 12/11/2020
• Supplement Dates FDA Received: 08/08/2022; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization