MAUDE Adverse Event Report: CONMED CORPORATION LEEP ELECTRODES; 5MM BALL ELECTRODE

Catalog Number 60-5181-103

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)(6) rejected (b)(4) esp accessory ball, 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 a device malfunction with potential of injury upon reoccurrence.

Manufacturer Narrative

Complaint is not confirmed.Received one 60-5181-103 in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested, which indicated that the packaging did not have an insufficient heat seal.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 never be used when: there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic, these devices fail the inspection described herein.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LEEP ELECTRODES
• Type of Device: 5MM BALL ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8734497
• MDR Text Key: 149196861
• Report Number: 1320894-2019-00199
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K913213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 60-5181-103
• Device Lot Number: 201810011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1