MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 10K24K ARTHROSCOPY INFLOW TUBE SET; ATHROSCOPY TUBING

Model Number	10K100
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned, however the complaint investigation is ongoing.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed (b)(4) reported on behalf of their customer that the 10k100, linvatec arthroscopy tubing set, was used for an arthroscopic procedure on (b)(6) 2020.A foreign material was found inside the cassette post op.It could also be visible on the back table in the saline solution.At this time, no determination has been made as to what the material is, but an investigation is underway.There is no reported patient injury or impact.There has been no reported delay of procedure.The procedure was completed as planned, as this was found post procedure.This report is being raised as device malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the returned used could not confirm the reported problem.Provided photos show evidence of particulate inside the cassette however the lot number of the device in the photo cannot be ascertained.Examination performed per print 10k100 rev bd.Product containing the particulate was sent to a 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.Additionally, the peaks of sodium, chlorine, iron, potassium and magnesium might possibly be due to remnant iv solutions utilized during use of the tubing sets.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 were found to have met all specifications prior to shipment.A 2 year lot history review was conducted and found 2 events with a quantity of 19 units for this lot number.A two-year review of complaint history revealed there has been 60 complaints regarding 191 devices for this device family and failure mode.During the same time frame 890,706 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0002 per the instructions for use, the user is advised the following; - that tubing sets should only be used if the original packaging and labeling are intact.- conmed encourages the inspection and/or test of all medical equipment prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 10K24K ARTHROSCOPY INFLOW TUBE SET
• Common Device Name: ATHROSCOPY TUBING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• MDR Report Key: 9660324
• Report Number: 3007305485-2020-00010
• Device Sequence Number: 14293689
• Product Code: HRX
• UDI-Device Identifier: 10845854041208
• UDI-Public: (01)10845854041208(17)240701(30)1(10)201907035
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 10K100
• Device Catalogue Number: 10K100
• Device Lot Number: 201907035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1