MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN 1 IN. BLADE EXTENDED INSULATION; LECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 139104EXT

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

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

On behalf of the customer, the distributor reported an issue with the ultraclean 1 in.Blade extended insulation, item (b)(4), unknown lot, that occurred on (b)(6) 2019 in (b)(6) during an unknown procedure.The information indicates that "user said that he pinched the insulation tube and insulation tube was came off from active electrode easy.The condition of shrink was like an imperfect."it is indicated there was no impact or injury to the patient and the procedure was successfully completed using another device with no reported delay.Additional information obtained notes that only the insulation fell off into the patient while the device was in use.It was confirmed there was no injury to the patient.No other clarification was made available.This report is being raised on the basis of previous filings for malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event of the insulation falling off is confirmed.Conmed received one 139104ext in unoriginal packaging.The lot number was not verified as the device lot number was not listed on the device.A visual inspection was performed and confirmed the blue shrink tube was detached from the device.When placing the blue shrink tube back over the blade, it was apparent that the tubing was not shrunk to the device enough.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised that these devices should be inspected before and after each use.Visually examine the devices for obvious physical damage including cracked, broken or otherwise distorted plastic parts; damage including cuts, puncture, nicks, abrasions or unusual lumps, significant discoloration; and verify that the electrode is fully and securely seated in the handpiece before use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN 1 IN. BLADE EXTENDED INSULATION
• Type of Device: LECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9532220
• MDR Text Key: 198559322
• Report Number: 3007305485-2019-00441
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K991855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 139104EXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1