MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LINVATEC ARTHROSCOPY INFLOW/OUTFLOW TUBING SET.; ARTHROSCOPE

Catalog Number 10K150

Device Problem Particulates (1451)

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

Event Type  malfunction  

Manufacturer Narrative

Additional product code ; gcj.The device in question has been received by conmed and has entered into the evaluation process.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of their customer, good doctor tuenteun hospital, the distributor ib medical, reported to conmed (b)(4) issues with the 10k150, linvatec arthroscopy inflow/outflow tubing set.It was reported that the device was used, exact date unknown, for an arthroscopic procedure, either psld, a/s knee, a/s shoulder.A foreign material was found inside the cassette of the tubing post operatively.They were unable to determine what the material is.There is no reported patient injury or impact and the procedures were completed with no reported delay.Although requested, no other additional information is available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to the unknown foreign debris which was removed.

Manufacturer Narrative

The reported event of foreign material found inside cassette post-op is confirmed.A visual examination of the returned new item 10k150, confirmed debris inside returned product cassette.The cassette membrane was removed, and white particulate was found.The product was not returned in the original conmed shipping bag.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only event with a quantity of 10 units for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that tubing sets should only be used if the original packaging and labeling are intact.A determination for further investigation was made and a manufacturing process review initiated for this device family and issue.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LINVATEC ARTHROSCOPY INFLOW/OUTFLOW TUBING SET.
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11222552
• MDR Text Key: 228440023
• Report Number: 3007305485-2021-00035
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K033573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10K150
• Device Lot Number: 202002144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1