MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPE SHEATH, REUSABLE; INNER SHEATH FOR RESECTOSCOPE

Model Number	26050CA
Medical Device Problem Codes	Material Separation (1562); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during a laser auriga 30 fragmentation of a large bladder stone with the storz resector, the ceramic tip broke off and passed into the bladder.This forced the surgeon to do a laparotomy to recover the part inside the lava.The ceramic completely separated from the sheath and passed into the bladder.The surgery was prolonged for 1h 30 minutes.The resection of the prostate was rescheduled 15 days later.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was returned on 2023-09-07.The investigation of the product was completed on 2023-11-29.The evaluation of the product revealed that the articles in question were repaired by a third party.It is therefore very likely that the external company did not fulfill karl storz's quality requirements.At the distal end, the shaft of two articles was most likely machined too much, so that the wall of the tube was too thin and the connection between the ceramic beak and the tube was no longer given.On the third shank there is no recognizable glue residue, which has resulted in the ceramic beak having no connection to the shank.The missing connection between the ceramic beak and the shank, caused the ceramic to fall off.As described in the ifu that the articles needs to be checked for intactness before use, these damages should have been noticed, therefore, apart from the external repair, a user error is not excluded.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPE SHEATH, REUSABLE
• Common Device Name: INNER SHEATH FOR RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17671662
• Report Number: 9610617-2023-00229
• Device Sequence Number: 17770425
• Product Code: HIH
• UDI-Device Identifier: 04048551007228
• UDI-Public: 4048551007228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26050CA
• Device Catalogue Number: 26050CA
• Device Lot Number: ST01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 11/29/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/04/2023; 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown