MAUDE Adverse Event Report: BUFFALO FILTER LAPAROSCOPIC SMOKE EVAC TUBING SET; APPARATUS, EXHAUST, SURGICAL

Catalog Number 60-6810-001

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

During incoming inspection, the distributor rejected this device, catalog # 60-6810-001, laparoscopic smoke evac tubing set , lot 140843, for a possible insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Due to the potential severity of a breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

D10, h3: although the device in question is manufactured by buffalo filter, a preliminary evaluation was performed by conmed.The device will be forwarded on to buffalo filter, the manufacturer as well.H10: the reported event of insufficient heat seal is confirmed.Conmed received one 60-6810-001 in unopened original packaging.The lot number was verified.A visual inspection was performed and found the seal was not lined up properly.Performed a functional inspection with dye leak testing per procedure which indicated that the packaging did have an insufficient heat seal.Although a lot number was provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record (dhr) as the device is manufactured by buffalo filter for conmed.A risk analysis cannot be conducted for this device since conmed does not own the risk documents for this device.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 1 complaints, regarding 1 device, for this device family and failure mode.During this same time frame 77,955 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LAPAROSCOPIC SMOKE EVAC TUBING SET
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): BUFFALO FILTER; 8388 bridlewood drive; e. amherst, ny
• MDR Report Key: 9706035
• MDR Text Key: 183307262
• Report Number: 1320894-2020-00068
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• PMA/PMN Number: K924732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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
• Device Operator: No Information
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 60-6810-001
• Device Lot Number: 140843
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1