MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC 10K; ARTHROSCOPE

Catalog Number 10K100

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

Arthroscopy tubing suspected of possible leak.Tubing changed out and worked appropriately.No patient injury or harm.

• Brand Name: 10K
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept blvd; largo FL 33773
• MDR Report Key: 3598866
• MDR Text Key: 4193129
• Report Number: 3598866
• Device Sequence Number: 1
• Product Code: NBH
• 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: 01/10/2014

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: Nurse
• Device Catalogue Number: 10K100
• Device Lot Number: 1310014
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR