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

Model Number	11582M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bending not able to go all the way through, too thin.Happened during a case.Surgeon was not able to complete the procedure, cross reference mdr: 9610617-2024-00505.
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).

• 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
• MDR Report Key: 20916029
• Report Number: 2020550-2024-00499
• Device Sequence Number: 8476286
• Product Code: GCJ
• UDI-Device Identifier: 04048551051863
• UDI-Public: 04048551051863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024
• Report Date (Section F): 12/12/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown