MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE

Device Problem Leak/Splash (1354)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

On 12/15/2023, it was reported by a sales representative that an (b)(6) sheath seal was damaged and caused leaking.This was discovered during a procedure.The patient was not affected and there were no adverse events.The case was completed as normal, and the staff relied on the drape to collect the dripping arthroscopy fluid.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18494930
• MDR Text Key: 333198076
• Report Number: 1220246-2024-00282
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: 00888867198579
• 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: 01/11/2024

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
• Device Operator: Health Professional
• Device Model Number: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4002
• Device Lot Number: 1656492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1