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

Catalog Number	130309A
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/13/2024
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 for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer, that the 130309a, goldline, button, holster was being used during an unknown procedure on 13feb24 date when it was reported ¿when they plugged the pen it activated itself, with esg-400 not able to be reproduced by biomed.The hospital but they informed me there was 3 burns to the patient that they didn¿t mention when they sent it to me further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with an unknown alternate device and a 2-minute delay was reported.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to unknown degree of burn.
Event or Problem Description
The sales representative reported on behalf of the customer, that the 130309a, goldline, button, holster was being used during an unknown procedure on (b)(6) 2024 date when it was reported ¿when they plugged the pen it activated itself, with esg-400 not able to be reproduced by biomed.The hospital but they informed me there was 3 burns to the patient that they didn't mention when they sent it to me further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with an unknown alternate device and a 2-minute delay was reported.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to unknown degree of burn.
Additional Manufacturer Narrative
Received one 130309a in opened original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised to use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effect.Activation time should be as short as possible.Never allow the cables connected to these devices to be in contact with skin of the patient or operator during electrosurgical activations.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: GOLDLINE, BUTTON, HOLSTER
• 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: 18887804
• Report Number: 3007305485-2024-00035
• Device Sequence Number: 3051578
• Product Code: GEI
• UDI-Device Identifier: 30653405056151
• UDI-Public: (01)30653405056151(17)280813(10)202308155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 130309A
• Device Lot Number: 202308155
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic