MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRACLEAN 6 IN. BLADE 50/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 139107

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 03/23/2023

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the 139107 ultraclean 6 in.Blade 50/case was being used on (b)(6) 2023 during a breast augmentation procedure and ¿a patient burned by a bovie tip electrode, not functioning.".The patient received a burn.It was reported that, "the electrodes protective covering separated from the grey and blue area leaving the metal exposed causing a small 4mm size second/third degree burn to the corner of the tissue at the incision." there was a minor delay of a couple minutes.The patient was discharged home without issues and there was no extended hospitalization.This report is being raised on the basis of injury due to patient receiving 3rd degree burn.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the (b)(6) ultraclean 6 in.Blade 50/case was being used on (b)(6) 2023 during a breast augmentation procedure and ¿a patient burned by a bovie tip electrode, not functioning.".The patient received a burn.It was reported that, "the electrodes protective covering separated from the grey and blue area leaving the metal exposed causing a small 4mm size second/third degree burn to the corner of the tissue at the incision." there was a minor delay of a couple minutes.The patient was discharged home without issues and there was no extended hospitalization.This report is being raised on the basis of injury due to patient receiving 3rd degree burn.

Manufacturer Narrative

Update: medical device code corrected from (b)(6).Manufacturer narrative: the device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.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 was found to have met all specifications prior to shipment.A 2 year lot history review shows 2 events for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of(b)(4), regarding 8 devices, for this device family and failure mode.During this same time frame (b)(4) 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).Per the instructions for use, the user is advised the following: 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.Verify that the electrode is fully and securely seated in the handpiece before use.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN 6 IN. BLADE 50/CASE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16692221
• MDR Text Key: 312863240
• Report Number: 3007305485-2023-00076
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 40653405007303
• UDI-Public: (01)40653405007303(17)260517(10)202105185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 139107
• Device Lot Number: 202105185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic