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

Model Number	11573M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Salivary Gland Problem (4484)
Date of Event	02/19/2025
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 when removing the salivary duct stone, the collection basket broke off.The salivary duct had to be opened.Bleeding occurred and the duration of the operation doubled.
Additional Manufacturer Narrative
Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information was received that the planned surgery time was 75 minutes, prolongation of the surgery was 20 minutes.The patient needed to stay one night in the hospital.
Additional Manufacturer Narrative
The device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection is not possible.The evaluation was done based on the information provided by the customer: when removing the salivary duct stone, the collection basket broke off.Possible causes include attempting to pick up a stone that was too large or applying excessive force to the wires.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: 21595066
• Report Number: 9610617-2025-00429
• Device Sequence Number: 18374073
• Product Code: GCJ
• UDI-Device Identifier: 04048551276938
• UDI-Public: 04048551276938
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/02/2025

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: 11573M
• Device Catalogue Number: 11573M
• Device Lot Number: 014125010
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 06/25/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/02/2025
• 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; Required Intervention
• Patient Sex: Unknown