MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LINVATEC 10K / 24K ARTHROSCOPY INFLOW TUBING SET; ARTHROSCOPE

Catalog Number 10K100

Device Problem Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional product code; gcj.At time of filing, although expected, the reported device has not been returned to conmed for evaluation.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

Conmed (b)(4) received a report of issues with the 10k100, linvatec 10k / 24k arthroscopy inflow tubing set, lot 202010154.It was reported that during proctology robotic surgery involving a (b)(6) female, white debris was found.The white debris was removed using a suction.The surgery was successfully completed without an alternative but with a 15minute delay.It is indicated that there was no impact or injury to the patient.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 customer complaint of white debris found was confirmed per provided photos.Debris allegedly returned in a small plastic battle could not be found.However, provided photos shows debris found during case.Previously, 10k100 product containing the particulate was sent to an outside lab for analysis.Elemental composition of the white particulate found during analysis of the particulate is most likely particles that abraded during insertion of the spikes into the leak tester.The chemical elements found at that time are consistent with the composition of the product components, adhesives and equipment used for manufacture of the product.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 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.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use.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 10K / 24K ARTHROSCOPY INFLOW 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: 11193346
• MDR Text Key: 255490287
• Report Number: 3007305485-2021-00028
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10K100
• Device Lot Number: 202010154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 02/03/2021
• Patient Sequence Number: 1