MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY LAP PROBE,5 MM, H/SWITCHABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	160656
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5115028 on 27feb23.The report was found to be written against the 160656, lap probe,5 mm, h/switchable device that was being used during a nephrectomy procedure on (b)(6) 2023.The report stated, ¿during argon coagulation of l (left) renal mass site, the surgeon noted additional char sites on the exterior of the kidney (cortex).When inspected the argon beam handle was melted through and burned kidney at an unintended place.¿ further assessment questioning found that ¿no change to function, char expected to heal¿.The procedure was completed without delay and there was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of injury due to kidney obtaining a burn.
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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
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.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 the following: do not directly secure the handpiece cord to surgical drapes with metal instruments.Activation of the handpiece in contact with metal instruments may cause burns at the tissue/instrument interface.Do not activate the electrosurgical unit, if the tip of the instrument is not in a position to deliver energy (fulguration) to target tissue.Doing so may cause inadvertent burns to patient.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 sup-ply hose does not become kinked or crimped.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5115028 on 27feb23.The report was found to be written against the 160656, lap probe,5 mm, h/switchable device that was being used during a nephrectomy procedure on (b)(6) 2023.The report stated, ¿during argon coagulation of l (left) renal mass site, the surgeon noted additional char sites on the exterior of the kidney (cortex).When inspected the argon beam handle was melted through and burned kidney at an unintended place.¿ further assessment questioning found that ¿no change to function, char expected to heal¿.The procedure was completed without delay and there was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of injury due to kidney obtaining a burn.

• Brand Name: LAP PROBE,5 MM, H/SWITCHABLE
• 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: 16551670
• Report Number: 3007305485-2023-00055
• Device Sequence Number: 5089017
• Product Code: GEI
• UDI-Device Identifier: 30653405003896
• UDI-Public: (01)30653405003896(17)270712(10)202207134
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K925903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Model Number: 160656
• Device Catalogue Number: 160656
• Device Lot Number: 202207134
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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