MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 05/16/2024, it was reported by a facility representative via sems-06570438 that an ar-3372-2402 sheath was bent during a procedure.Another sheath was used to complete the case.Case/patient involvement not indicated.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3373-2402 serial/batch number (b)(6) was received for investigation.Visual inspection noted that the shaft of the sheath was bent.The distal end was also deformed.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.Per dfu-0073-6; g; 4-6: "do not subject the endoscope and endoscopic medical instruments to impact.Put the endoscope and endoscopic medical instruments down carefully.5.Hold the endoscope only by the ocular funnel/main part and not by the sheath.6.Do not bend the sheath or use as a prying tool.

• Brand Name: SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19524682
• Report Number: 1220246-2024-05645
• Device Sequence Number: 12864893
• Product Code: NBH
• UDI-Device Identifier: 00888867198470
• UDI-Public: 00888867198470
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
• Device Catalogue Number: AR-3372-2402
• Device Lot Number: 1459338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown