MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRACLEAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	139105EXT
Medical Device Problem Codes	Material Fragmentation (1261); Sparking (2595)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the 139105ext, accessory electrode coated needle with extended insulation, device was being used in an unknown procedure on 05dec24 when it was reported, ¿the electrode started sparking and then the plastic covering fell off splitting inside the patient.".Further assessment was attempted, and a good faith effort was completed but to date no further information is available.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on reported injury due to the possibility of the patient retaining a foreign body.
Additional Manufacturer Narrative
Correction: additional information updated in b5 this has changed this complaint and has been changed from a serious injury to a malfunction.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 8 complaints, regarding 44 devices, for this device family and failure mode.During this same time frame 9,287,235 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 0.000005.Per the instructions for use, the user is advised 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.Improper electrode installation may result in injury to the patient or operating room personnel by arcing at the pencil/electrode connection.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the 139105ext, accessory electrode coated needle with extended insulation, device was being used in an unknown procedure on (b)(6) 2024 when it was reported, ¿the electrode started sparking and then the plastic covering fell off splitting inside the patient.".Further assessment was attempted, and a good faith effort was completed but to date no further information is available.There was no report of injury, medical intervention, or extended hospitalization for the patient.Update: the customer confirmed that this event occurred during a breast procedure and the fragment was retrieved from the patient by hand.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRACLEAN
• Common Device Name: 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: 21025687
• Report Number: 3007305485-2024-00202
• Device Sequence Number: 20880775
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)290122(10)202401245
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 139105EXT
• Device Lot Number: 202401245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic