MAUDE Adverse Event Report: CONMED CONMED ARTHROSCOPIC SHAVER; ARTHROSCOPY SHAVER

Model Number CUDA 3.5MM

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/23/2017

Event Type  malfunction  

Event Description

Conmed arthroscopy shaver had what appeared to be tiny metal shavings released into knee joint while doctor performed an arthroscopic knee meniscectomy and debridement.No harm to pt.Circulating nurse saw shavings on video monitor while viewing knee joint.Vendor sales reps of conmed arthroscopic blade products was notified.

• Brand Name: CONMED ARTHROSCOPIC SHAVER
• Type of Device: ARTHROSCOPY SHAVER
• Manufacturer (Section D): CONMED; utica NY
• MDR Report Key: 6375959
• MDR Text Key: 69147348
• Report Number: MW5068237
• Device Sequence Number: 1
• Product Code: GFA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2017

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: CUDA 3.5MM
• Device Lot Number: 755226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR