MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE EXTRACTOR, 0.4 MM, 4 WIRES

Model Number	11582M
Medical Device Problem Codes	Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that bending not able to go all the way through, too thin.It was not possible to complete the procedure with the use of the stone extractor as intended.An incision was made to remove the stone.Cross reference mdr: 9610617-2024-00499.
Additional Manufacturer Narrative
Device evaluation: since no article was sent in for investigation, the customer's description cannot be confirmed.According to the customer, something is bent, but it is unclear whether it is the stone basket or the shaft.A possible root cause in relation to the description could be, for example, that the shaft was bent during insertion or that the stone basket was damaged due to mechanical overload.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: STONE EXTRACTOR, 0.4 MM, 4 WIRES
• Common Device Name: STONE EXTRACTOR, 0.4 MM, 4 WIRES
• 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: 20915537
• Report Number: 9610617-2024-00505
• Device Sequence Number: 7824887
• Product Code: GCJ
• UDI-Device Identifier: 04048551051863
• UDI-Public: 04048551051863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 11582M
• Device Catalogue Number: 11582M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown