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

Catalog Number 139104EXT

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261); Material Separation (1562)

Patient Problem Burn(s) (1757)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

The device in question, used in the procedure, is not available for evaluation by conmed.The facility is expected to return a stock sample of the same lot number.At time of filing, although expected, the stock sample 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

The customer reported an issue with the ultraclean 1 in.Blade extended insulation, item 139104ext, lot 201910254, that occurred on (b)(6) 2020 during a tonsillectomy at surgery center of (b)(6).It was reported that "the end of the extension on the product that protects the patient, it fell off and burn the patient during surgery".Additional information obtained from the reporter clarified that during a tonsillectomy on a (b)(6) patient, the insulation fell off the electrode and burned the patient.Information provided from the facility incident report notes the doctor was almost done with the procedure.He inserted the ultraclean electrode into the patients mouth.The whole blue insulation sleeve came off while being inserted into patient's mouth, with the blade burning the side of tongue.As the doctor was removing electrode blade, it burned the other side of the tongue.The blue insulation was removed from the patients mouth.No fragments remained.The procedure was successfully completed with no reported delay.The reporter mentioned she thought that the burns were "extensive" and "pretty bad" but there was no notation in the facility's report regarding the degree of burn sustained or immediate treatment provided.There was no additional follow up scheduled specific to the burn, only that the doctor will followup with the patient as normal regarding the tonsillectomy.The reporter explained that the device used in the procedure was disposed of at the facility.They are returning all their stock samples with the same lot number, confirmed to be 201910254, this report is being raised on the basis of injury.

Manufacturer Narrative

Additional clarification was made to the findings of the evaluation conducted by conmed.It was previously reported "the customer's reported complaint of the insulation falling off the electrode was confirmed.Conmed received twenty-four 139104ext in original packaging.The lot number was verified.A visual inspection was performed and there were no obvious signs of abnormalities or defects.A functional inspection was performed and found the blue insulation pulls off the blade with ease." clarification was made to the report.Findings now read " the customer's reported complaint of the insulation falling off the electrode was confirmed.Conmed received twenty-four 139104ext all in original packaging.The lot number was verified for eighteen devices as the reported lot, 201910254, the other six had a lot number of 201901294.A visual inspection was performed and found on five of the devices, lot number 201910254, the blue insulator was not seated properly.Nineteen of the devices, 14 devices with the lot number 201910254, 5 devices with the lot number 201810094, had no obvious signs of abnormalities or defects.A functional inspection was performed and found the blue insulation pulls off the blade with ease on five out of the 24 devices, lot number 201910254.The other information previously submitted remains unchanged and correct.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The customer's reported complaint of the insulation falling off the electrode was confirmed.Conmed received twenty-four 139104ext in original packaging.The lot number was verified.A visual inspection was performed and there were no obvious signs of abnormalities or defects.A functional inspection was performed and found the blue insulation pulls off the blade with ease.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 and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 66 devices, for this device family and failure mode.During this same time frame 3,272,245 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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The user is 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, punctures, nicks, abrasions, unusual lumps, significant discoloration and verify that the electrode is fully seated in the handpiece before use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN ELECTRODE, 1 IN. BLADE, EXTENDED INSULATION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9648612
• MDR Text Key: 187101405
• Report Number: 3007305485-2020-00019
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 139104EXT
• Device Lot Number: 201910254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/15/2020; 03/13/2020
• Supplement Dates FDA Received: 03/13/2020; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR