MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY PENCIL,ABC,BEND-A-BEAM,6" LONG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 134006

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 03/28/2024

Event Type  Injury  

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.

Event Description

The sales representative reported on behalf of the customer that the device, 134006, pencil, abc, bend-a-beam, 6" long, was being used on (b)(6) 2024 when it was reported ¿dr.Was performing a liver resection and when he pulled the helix argon 6" bend a beam hand piece the tip was on fire.This is the second time in the last few months that this has happened with the same hand piece, with the same surgeon.".There was no impact or injury to the patient; however, the surgeon was burned.Further assessment answers were requested of the reporter; however, no information has been received.The procedure was completed without the use of an alternate device.There was a 10-15 minute delay.This report is being raised on the reported injury due to burn of unknown degree to the surgeon.

Event Description

Update: per further assessment received on (b)(6) 2024, it was found "after meeting with multiple staff personal and biomed, we all came to the conclusion to the error was due to user error.There have been multiple complaints levied by this surgeon and there have been no issues reported by any other users.The safety board at methodist richardson felt confident that it was surgeon error and not product failure.I would close the complain if possible.".The sales representative reported on behalf of the customer that the device, (b)(6), pencil,abc,bend-a-beam,6" long, was being used on (b)(6)2024 when it was reported ¿dr.Was performing a liver resection and when he pulled the helix argon 6" bend a beam hand piece the tip was on fire.This is the second time in the last few months that this has happened with the same hand piece, with the same surgeon.".There was no impact or injury to the patient; however, the surgeon was burned.Further assessment answers were requested of the reporter; however, no information has been received.The procedure was completed without the use of an alternate device.There was a 10-15 minute delay.This report is being raised on the reported injury due to burn of unknown degree to the surgeon.

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.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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 the following: do not directly secure the cable with metal instruments to surgical drapes.Activation of the device in contact with metal instruments may cause burns at the tissue/instrument interface.Do not permit cables connected to associated electrosurgical accessories to be parallel to or in close proximity to the leads of other electrical devices.To avoid burns never allow cable associated with this device to be in contact with skin of patient or touching operator.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PENCIL,ABC,BEND-A-BEAM,6" LONG
• Type of Device: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19124916
• MDR Text Key: 340382423
• Report Number: 3007305485-2024-00058
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405002752
• UDI-Public: (01)30653405002752(17)281113(10)202311154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 134006
• Device Lot Number: 202311154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic