MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH

Device Problem Material Opacification (1426)

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

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

On (b)(6) 2023, it was reported by a facility representative via sems that an ar-3355-2430 scope has several black spots and a dark shadowed area in the field of view.This was discovered during an arthroscopic procedure.The case was completed by using a new scope with no patient harm.

• Brand Name: C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH
• 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: 17343619
• MDR Text Key: 319597583
• Report Number: 1220246-2023-07196
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867101470
• UDI-Public: 00888867101470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH
• Device Catalogue Number: AR-3355-2430
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1