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

Catalog Number 10K100

Device Problem Material Fragmentation (1261)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional fda product code: gcj.The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 10k100 device was being used during a cholelithotomy on approximately (b)(6) 2020 when "white debris was found during surgery".The procedure was reported as being completed as planned and there was no report of injury, medical intervention or hospitalization for the patient.Further assessment information was requested; however, not all of the questions have been answered to date.It is unknown if the debris came into contact with the patient during surgery or if it did come into contact with the patient if all the debris was removed.This report is being raised on the basis of injury due to unknown contact and/or removal from the patient.

Manufacturer Narrative

Correction: due to receiving follow up assessment information that there was no debris left in the patient, the following sections have been updated for the change of this filing from an injury to malfunction: b1, b2, b5, h1 manufacturer narrative: visual examination of returned new item 10k100, qty.Of 10 confirmed debris inside returned product.Per sterile package particulate & seal width chart, t30-003-140, rev-ac and si-000-092, rev-al foreign substance is not acceptable.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 11 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 0.00008.Per the instructions for use, the user is advised: if packaging has been opened or altered, do not use.Sterile integrity may be compromised.Contact your local conmed linvatec representative, or in the u.S.Contact the customer service department.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 10k100 device was being used during a cholelithotomy on approximately 17nov20 when "white debris was found during surgery".The procedure was reported as being completed as planned and there was no report of injury, medical intervention or hospitalization for the patient.Further assessment information was requested; however, not all of the questions have been answered to date.It is unknown if the debris came into contact with the patient during surgery or if it did come into contact with the patient if all the debris was removed.Recvd 16dec20 - after operating 10k pump, it was found that there were foreign materials in the saline solution.A surgeon removed debris using a suction, and used another 10k100 to complete the surgery successfully.This will change the category of this filing from an injury to a malfunction because all debris was removed during suctioning.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 10975145
• MDR Text Key: 220426695
• Report Number: 3007305485-2020-00540
• 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
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10K100
• Device Lot Number: 202004075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 12/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR