MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HIGH-FLOW ARTHROSCOPE SHEATH

Model Number	28136DS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "arthroscopy surgery successfully performed on a patient around (b)(6) 2025.The patient reported post operation pains in his knee.The patient's post operation x-ray exam revealed a remaining foreign body in his knee.The patient was operated again around (b)(6) 2025 to remove the part that was deemed missing from the sheath used during the surgery".
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.
Additional Manufacturer Narrative
Correction: section b2 "congenital anomaly/birth defect" selected in error.

• Brand Name: HIGH-FLOW ARTHROSCOPE SHEATH
• Common Device Name: HIGH-FLOW ARTHROSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22176852
• Report Number: 2020550-2025-00988
• Device Sequence Number: 15766753
• Product Code: HRX
• UDI-Device Identifier: 04048551267219
• UDI-Public: 04048551267219
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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,Followup
• Report Date (Section B): 06/10/2025
• Report Date (Section F): 06/06/2025

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: 28136DS
• Device Catalogue Number: 28136DS
• Device Lot Number: PN02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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: Congenital Anomaly; Required Intervention
• Patient Sex: Unknown