MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT TUBE SET, SMOKE EVAC, LAPAROSCOPIC; APPARATUS, EXHAUST, SURGICAL

Catalog Number 60-6810-001

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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, tube set, smoke evac, laparoscopic, catalog # 60-6810-001, lot 145054, for a possible insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(4).Due to the potential severity of a possible breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The customer's reported complaint of an insufficient heat seal leading to a breach in sterility is confirmed.Conmed received one 60-6810-001 in unopened original packaging, the reported catalog and lot numbers were verified.A visual inspection was performed and found there is a large open hole in the seal, which indicates that the packaging did have a breach in sterility.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame 513,645 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 0.00003 conmed encourages the inspection of all medical equipment, labeling and packaging prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: TUBE SET, SMOKE EVAC, LAPAROSCOPIC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 10627292
• MDR Text Key: 222400837
• Report Number: 3007305485-2020-00439
• 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: 12/30/2020

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: 12/09/2021
• Device Catalogue Number: 60-6810-001
• Device Lot Number: 145054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1