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

Model Number	11582M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The 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 the during a sialoendoscopy a breakage occurred.Foreign material was left inside the patient.No harm to patient, user or third reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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
Device evaluation: the product was returned to manufacture on january 13,2025, and investigation completed on february 5,2025.The customer's complaint has been confirmed.The hose nozzle/insulation has separated approximately 20 mm from the distal end.As a result, the loose part moves forward when the catch basket is actuated or extended, restricting its functionality.The most probable cause of the issue is user error the stone catcher appears to have been cut at a sharp point due to shaft movement.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: 21074387
• Report Number: 9610617-2025-00013
• Device Sequence Number: 18267098
• Product Code: GCJ
• UDI-Device Identifier: 04048551051863
• UDI-Public: 04048551051863
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 02/05/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025; 02/25/2025
• 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: Other
• Patient Sex: Unknown