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

Model Number	28136DS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Product requested but not yet received.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was a malfunction with a 28136ds high flow arthroscope sheath.According to the information received the doctor completed a shoulder arthroscopy case on (b)(6) 2023.The follow up x-ray was completed on (b)(6) and found that the top fenestrated peace of the dual stopcock sheath was broken and stayed in the patient's shoulder soft tissue.Patient harm is not known at date of this report.Additional patient information is not available.The patient is scheduled for a second surgery to remove the broken piece.
Additional Manufacturer Narrative
Per manufacture: since the product was not sent for examination (also no pictures, etc.) cannot be determined an exact cause.Due to the age, however, it is assumed that the article has worn out over the years / is tired and thus came to breakage.Product history: no abnormalities.Internal complaint number is (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; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 east grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17324546
• Report Number: 9610617-2023-00157
• Device Sequence Number: 14824547
• Product Code: HRX
• UDI-Device Identifier: 04048551267219
• UDI-Public: 4048551267219
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: RV07
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 22 YR
• Patient Sex: Female