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

Catalog Number	139105EXT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional 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.We will continue to monitor per regulatory requirements to help ensure patient safety.Device not yet returned.
Event or Problem Description
Conmed japan reported on behalf of the customer that the 139105ext, accessory electrode coated needle was being used on (b)(6) 25 during a resection of head tumor procedure when it was reported ¿a physician was using 20a 139105ext and closed the wound on a patient without noticing that the tip was broken.After closing the wound, he discovered that the tip of the product was broken.After the surgery, an x-ray was performed, but the tip could not be found.The surgery was completed without finding it, and the patient was informed that there was a possibility that the product was left behind.¿.The procedure was completed without the use of an alternate device.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.
Event or Problem Description
Conmed japan reported on behalf of the customer that the 139105ext, accessory electrode coated needle was being used on (b)(6) 2025 during a resection of head tumor procedure when it was reported ¿a physician was using a 139105ext and closed the wound on a patient without noticing that the tip was broken.After closing the wound, he discovered that the tip of the product was broken.After the surgery, an x-ray was performed, but the tip could not be found.The surgery was completed without finding it, and the patient was informed that there was a possibility that the product was left behind.¿.The procedure was completed without the use of an alternate device.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
Reported event of ¿tip of the product was broken, there was a possibility that the product was left behind¿ was confirmed.Examination of returned used device 139105ext found that the tip had been fractured, but the part of the tip that had broken off was not returned.Visual inspection also found that the blue material covering the electrode was loose and could be completely removed.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that the device was pushing against other devices during manipulation.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.(b)(4).Per the instructions for use, the user is advised that 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.

• 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 ; 3152231084
• MDR Report Key: 21933479
• Report Number: 3007305485-2025-00079
• Device Sequence Number: 9031585
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)280814(10)202308164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 202308164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic