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

Catalog Number	160656
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the 160656, abc probe 5 mm handswitching probe, 28 cm, was being used on (b)(6) 2025 during an unknown procedure on (b)(6) 2025 when it was reported ¿argon tip split and broke while in a patient today.No apparent harm to patient, no retained objects.Switched to new device and saved defective one".¿ the procedure was completed with the alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.The current status of the patient was reported as ¿stable¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.H3 other text: device not yet received.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.If the device is returned, at a later date, the investigation may be updated and reanalyzed.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 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 12 devices, for this device family and failure mode.During this same time frame (b)(4) 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).Per the instructions for use, the user is advised before use, inspect the cord insulation and handpiece integrity and condition.If damaged, chipped, cut, or nicked, do not use the handpiece/probe.Inspect the probe for any damage.Do not use if you suspect any damage is present.Notify the manufacturer immediately.Use of the handpiece without gas flow may cause severe tip damage.Make certain the abc connector is fully seated into the gas supply receptacle and make sure the gas supply hose does not become kinked or crimped.(always test for gas flow prior to surgical use by activating the handpiece and directing the active tip toward pooled fluid.Appropriate gas flow will result in fluid dispersion prior to establishment of argon beam.) we will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the 160656, abc probe 5 mm handswitching probe, 28 cm, was being used on(b)(6) 2025 during an unknown procedure on (b)(6) 2025 when it was reported ¿argon tip split and broke while in a patient today.No apparent harm to patient, no retained objects.Switched to new device and saved defective one".¿.The procedure was completed with the alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.The current status of the patient was reported as ¿stable¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ABC
• 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: 21576794
• Report Number: 3007305485-2025-00044
• Device Sequence Number: 8346730
• Product Code: GEI
• UDI-Device Identifier: 30653405003896
• UDI-Public: (01)30653405003896(17)290820(10)202408214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 160656
• Device Lot Number: 202408214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic