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 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Secondary fda product code is gcj.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 customer reported that the device, 10k100, was being used during a cholelithotomy on (b)(6) 2020 when it was reported that "the hospital found the multiple white debris during the surgery and they said that they removed the visible white debris with a forcep as much as they can." the procedure was completed after a 30-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of injury due to not knowing if all debris was removed the patient.

Manufacturer Narrative

Product was returned in the original conmed shipping bag.Visual examination of returned item confirmed debris at the tube set.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.There have been 2 complaints for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use the user is advised that tubing sets should only be used if the original packaging and labeling are intact.A determination for further investigation has been initiated.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: 10823152
• MDR Text Key: 215887861
• Report Number: 3007305485-2020-00481
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10K100
• Device Lot Number: 202003275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR