MAUDE Adverse Event Report: CONMED CORPORATION 10K/24K ARTHROSCOPY INFLOW TUBE SET; ARTHROSCOPE

Model Number 10K100

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Arthroscopy tube set broke/leaked during the procedure.Fda safety report id# (b)(4).

• Brand Name: 10K/24K ARTHROSCOPY INFLOW TUBE SET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 10378953
• MDR Text Key: 202216883
• Report Number: MW5095945
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10K100
• Device Catalogue Number: 10K100
• Device Lot Number: 201909284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 35 YR