MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 3" BEND-A-BEAM MALABLE ABC HP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	134003
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint of the tip caught fire is not confirmed.Received one 134003 in opened original packaging.Lot number and catalog numbers were verified.Performed a visual inspection of the device, there was some charring at the tip.Performed a functional inspection of the device, the device would "spark" but would not function as intended and then shortly after would give an error.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: contraindications: these devices should never be used when: in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases, such as nitrous oxide, or in oxygen-enriched environments.Warning: always place handpiece in a safe insulated location when not in use, to avoid burns.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 134003 device tip caught fire during a cholecystectomy and liver resection on (b)(6) 2019.The event took place at the beginning of use of the argon beam.There was no delay in the procedure.There was no report of injury to the patient or user.The tip was extinguished by immediately dipping the device into saline.The procedure was completed successfully.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3" BEND-A-BEAM MALABLE ABC HP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8599208
• Report Number: 3007305485-2019-00146
• Device Sequence Number: 13969510
• Product Code: GEI
• UDI-Device Identifier: 30653405002745
• UDI-Public: (01)30653405002745(17)240124(10)201901254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K961505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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 Expiration Date: 01/24/2024
• Device Catalogue Number: 134003
• Device Lot Number: 201901254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 113