MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT PNCL,TO,STD,1"BD,10',HLS,NC,S; APPARATUS, ELECTROSURGICAL

Catalog Number 130321

Device Problem Arcing (2583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The alleged 130321 device is not expected to be returned for evaluation and review.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 130321, pncl,to.Std.1"bd,10',hls,nc.S, device was being used during a liver transplant procedure on (b)(6) 2019 when the user "slid out the blade to do some coag on the tissue.When (the user) pressed the coag button (the user) got an electric arc to a nearby forceps.This melted the tip of the blade.By mistake (the user) had selected spray coag instead of standard coag.(the user) also used 50w.That´s too high.This was a mistake by the staff and this is now corrected".There was no report of fragmentation or component falling into the patient.There was no report of user or patient injury; therefore, there was also no medical intervention or hospitalization required due to this event.The event did cause a 5-minute delay in the procedure; however, the procedure was completed successfully without having to use an alternate device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device, 130321, has not been returned for evaluation; however, the provided photographic evidence exhibits the reported failure.Per the sales and product manager, the generator has had changes made by disabling the "day to day" memory so that the generator will start every day with a preset setting of 0 watts.Then it was made that the generator had a preset program that can be chosen for this type of surgery.When chosen the settings will be correct and this failure will be avoided in the future.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: -there is visible evidence of damage to the exterior of the device, such as cracks, cuts, punctures, nicks, abrasions, discoloration or connector damage this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PNCL,TO,STD,1"BD,10',HLS,NC,S
• Type of Device: APPARATUS, ELECTROSURGICAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8381725
• MDR Text Key: 137708284
• Report Number: 3007305485-2019-00046
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• PMA/PMN Number: K871435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Catalogue Number: 130321
• Device Lot Number: 201803234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 5