MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LINVATEC 10K ARTHROSCOPY INFLOW/OUTFLOW TUBE SET; ARTHROSCOPY TUBING

Model Number	10K150
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report 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 or Problem Description
The customer reported that the 10k150 arthroscopy tubing set was used on (b)(6) 2020 during a laparoscopy procedure.During flushing the abdomen the doctor saw there were plastic parts into the tube and they went into the abdomen.The parts were removed under a big effort.Packaging was ok prior to procedure.Patient is o.K.This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination performed.Product samples from previously confirmed complaints, containing the particulate were sent to an outside 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.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 61 complaints regarding 192 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following; 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: LINVATEC 10K ARTHROSCOPY INFLOW/OUTFLOW TUBE SET
• Common Device Name: ARTHROSCOPY TUBING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 9750362
• Report Number: 3007305485-2020-00054
• Device Sequence Number: 3069141
• Product Code: HRX
• UDI-Device Identifier: 10845854041215
• UDI-Public: (01)10845854041215(17)240909(30)1(10)201909115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/10/2020

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: 09/09/2024
• Device Model Number: 10K150
• Device Catalogue Number: 10K150
• Device Lot Number: 201909115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1