MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE; ACCESSORIES, ARTHROSCOPIC

Model Number SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

Event Type  malfunction  

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 Description

It was reported on (b)(6) 2022 by a facility representative via sems that an ar-3372-2702 sheaths o-ring is falling apart.This was discovered during a procedure with no patient harm.

• Brand Name: SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13528222
• MDR Text Key: 288317219
• Report Number: 1220246-2022-04462
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867198494
• UDI-Public: 00888867198494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2022

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
• Device Operator: Health Professional
• Device Model Number: SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE
• Device Catalogue Number: AR-3372-2702
• Device Lot Number: 1574588
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/14/2022
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1