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 02/04/2021

Event Type  malfunction  

Event Description

The distributor reported on behalf of their customer that the 10k100 tubing was being used on (b)(6) 2021 during a proctology procedure when it was reported "a surgeon processed purge during pre-op testing, however, white debris was found inside of a patient's body during proctology surgery.White debris was removed from the patient's body." there was no report of medical intervention or any known hospitalization for the patient.There was no report of patient/user impact.The procedure was completed without an alternate device.There was a 5 minute delay.The lot number is unknown but reported to be one of the following: 202011185, 202010148, 202012085, 202012164, 202011234.Facility is unable to confirm which lot was involved with this incident.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Additional product code; 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.

Manufacturer Narrative

Reported event is confirmed.Debris returned in the small plastic bottle.A two-year lot history review could not be performed since a lot number was not provided.A review of the dhr could not be performed since a lot number was not provided.(b)(4).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: 11416994
• MDR Text Key: 280444886
• Report Number: 3007305485-2021-00098
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/23/2021
• Patient Sequence Number: 1