MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PROBE, 4 MM, 12 CM; ENDOSCOPIC SURGICAL PROBE

Model Number	28145W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2025
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 that during a routine l knee arthroscopy the knee structures were probed, with the device.Upon checking the acl the hook broke.The end was unretrievable.Arthrotomy was performed to no avail.The patient will be checked in the ongoing week.Metal still in knee.The initial surgery was aborted and had to switched to an open procedure (arthrotomy of knee).The broken off part could not be recovered.Additional x-rays were taken.As the end of the hook is embedded in the knee an initial aborted procedure, a switch to an open procedure, additional x-rays and a planned additional surgery, the event is deemed reportable.

• Brand Name: PROBE, 4 MM, 12 CM
• Common Device Name: ENDOSCOPIC SURGICAL PROBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21425473
• Report Number: 2020550-2025-00263
• Device Sequence Number: 7764384
• Product Code: LXH
• UDI-Device Identifier: 04048551095607
• UDI-Public: 04048551095607
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/20/2025
• Report Date (Section F): 02/20/2025

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: 28145W
• Device Catalogue Number: 28145W
• Device Lot Number: TR04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• 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: Required Intervention
• Patient Sex: Unknown