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

Catalog Number	130309A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/28/2023
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 customer reported that the 130309a, goldline, button, holster device was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿patient was burned.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.
Additional Manufacturer Narrative
Received one 130309a in unoriginal package.Lot number was not verified.Performed a visual inspection, no abnormalities or defects confirmed however, there is something applied to the distal end of the handpiece.Performed a functional inspection, the complaint was not confirmed, 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.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 13 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 that these devices should never be used when: there is visible evidence of damage to the exterior of the device such as cracked or damaged plastic or connector damage.These devices fail the inspection described herein.In the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o), or in oxygen-enriched environments.Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery.Additionally the ifu states 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 130309a, goldline, button, holster device was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿patient was burned.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.

• 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: 17956066
• Report Number: 3007305485-2023-00219
• Device Sequence Number: 20613011
• Product Code: GEI
• UDI-Device Identifier: 30653405056151
• UDI-Public: (01)30653405056151(17)271222(10)202212234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 130309A
• Device Lot Number: 202212234
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic