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.

• 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
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• 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
• Reporter Country Code: KS
• PMA/PMN Number: K033573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Catalogue Number: 10K100
• Device Lot Number: 202010154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage