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 op pains in his knee.The patient's post op 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.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the breakage is clearly attributable to user error.There are very strong signs of wear and tear, and all edges are deformed.Mechanical impact can therefore be assumed.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 22176546
• Report Number: 9610617-2025-00988
• Device Sequence Number: 18132009
• Product Code: HRX
• UDI-Device Identifier: 04048551267219
• UDI-Public: 04048551267219
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K963524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/23/2025; 11/03/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/02/2025; 11/05/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Required Intervention
• Patient Sex: Unknown