MAUDE Adverse Event Report: CONMED CORPORATION ARTHROSCOPY SHAVER; ARTHROSCOPE

Catalog Number C9254

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

Doctor used the sterilmed linvatec large cuda shaver during a knee scope.The shaver caused several small metal shavings in the knee.Doctor was able to irrigate the space and remove the metal shavings to prevent any harm to the patient.

• Brand Name: ARTHROSCOPY SHAVER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7005717
• MDR Text Key: 91224048
• Report Number: 7005717
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: C9254
• Device Lot Number: 2005924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2017
• Type of Device Usage: N
• Patient Sequence Number: 1