MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LINVATEC 10K100 ARTHR.TUBE SET; ARTHROSCOPE

Catalog Number 10K100

Device Problem Particulates (1451)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The reported device is being 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

The distributor reported on behalf of their customer that the device, 10k100, was being used on (b)(6) 2021 when "a surgeon processed purge during pre-op testing, however, white debris was found inside of a patient's body during gynecological cancer surgery (laparoscopy).White debris was removed from the patient's body." there was no report of impact or injury to the (b)(6) female patient.The procedure was completed without an alternate device.There was a 5 minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event "white debris was found inside of a patient's body" was confirmed based on photographic evidence and device evaluation.Device evaluation found white debris still attached to the tube set cassette.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.Chemical elements found 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 with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 50 complaints, regarding 2166 devices, for this device family and failure mode.During this same time frame 784,323 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.003.Per the instructions for use, the user is advised the following: tubing sets should only be used if the original packaging and labeling are intact.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LINVATEC 10K100 ARTHR.TUBE SET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11663796
• MDR Text Key: 250172447
• Report Number: 3007305485-2021-00196
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 202012165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 05/13/2021
• Patient Sequence Number: 1
• Patient Age: 55 YR