MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SINGLE FUNCTION HANDPIECE ABC ELECTRODE; APPARATUS, ELECTROSURGICAL

Catalog Number 130344

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported 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 Description

The distributor in (b)(4) rejected one (1) 130344, single function handpiece electrode, due to an "insufficient heat seal".In this instance, there was no patient involvement as the packaging anomaly was discovered during incoming inspection prior to distribution to an end-user.This report is being raised based on device malfunction with potential for injury with reoccurrence.

Manufacturer Narrative

One 130344 was received in unopened original packaging the reported catalog and lot numbers were verified.Visual inspection was unable to find any abnormalities or defects.Dye leak testing of the device packaging was unable to find a breach of the sterile barrier.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.(b)(4).Per the instructions for use, the user is advised the following; these devices should be inspected before each use.Visually examine the devices for obvious physical damage and do not use if damage is found: cracked, broken or otherwise distorted plastic parts.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SINGLE FUNCTION HANDPIECE ABC ELECTRODE
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 8296817
• MDR Text Key: 134742662
• Report Number: 3007305485-2019-00026
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• PMA/PMN Number: K871435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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: Other
• Device Expiration Date: 04/19/2023
• Device Catalogue Number: 130344
• Device Lot Number: 201804204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1