MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SUREFIT CORDLESS DUAL FOIL PAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 410-2200

Device Problems Connection Problem (2900); Positioning Problem (3009)

Patient Problem Burn(s) (1757)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received.At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the distributor in (b)(6) reported an issue involving the 410-2200, surefit cordless dual foil pad, serial # (b)(4), that occurred on (b)(6) 2020 at hospital (b)(6).It was reported that during an abdominoplasty with liposuction, the surgeon was across the table removing a skin flap from the left flank of the patient.The equipment had been in use for approximately 1 hour and a half.The scalpel had been used previously without any complications and the patient was placed in the folley position, plate on the right thigh, well positioned.The pen was being used to clot the fat at the time of the event.They smelled burning and noticed that the connection of the plate with cable had shifted.It was observed that the patient had a burn in the lateral region of the knee.According to the surgeon, the location of the burn was in the connector region.It is noted that the scalpel was in coagulation mode - 45w.Clarification of the treatment the patient received has been requested, however no additional information has been received as yet.The incident will be reported as an injury due to the reported patient burn.

Event Description

The following additional information was provided.The issue occurred a liposuction with abdominoplasty on a 38year old patient under general anesthesia, no vasoactive drug was used.Procedure duration was 7 hours.It is noted the plate was placed on the distal lateral part of the right femoral region.It was verified shortly after when the auxiliary surgeon came to surgery, that she felt a full burn in the room, began to remove the field from above the patient and found the burn in the 1/3 lateral mid of the mid.Before that, the patient had been placed in the fowler position for flap descent and skin removal.There were 5 people were on the medical team: principal surgeon, assistant, anesthetist, instrumentalist, circulating room.After talking to the surgeon in charge and the anesthetist who participated in the procedure they informed that after positioning the patient in a fowler position (necessary position to be adopted in this type of abdominoplasty surgery) and coincidentally with the arrival of the surgeon's assistant in the operating room, she reports feeling a burning smell in the environment, which made the team looked for where the smell came from, when discovering the patient removing the surgical field it was possible to find that the smell of burning came from the region near the location of the scalpel return plate.The surgeon then requested to exchange it to continue the procedure.The procedure was successfully completed.It is noted the patient was given proper care for the 3rd degree burn, such as the debridement of the burn, by the surgeon himself and his care after this procedure.All treatment of the burn has been completed at time of this filing.It was noted that a system 2450 generator with a t229 reusable cable was used.As a scar had been seen in provided pictures of the patient's burn, it was also confirmed there was no preexisting metal in the patient's knee.

Manufacturer Narrative

Conmed received one 410-2200 opened in unoriginal packaging.The lot number was not verified.A visual examination of the returned used device found the device was returned without connecting wires and dual pad was folded.Burn marks were observed on the side of the dual dispersive electrode.The reported claim of burn location in the connector region" is confirmed.Additionally, a provided photograph shows a burn to the patient's leg.Although the reported problem was confirmed, a root cause was not established.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that conductive parts of the pad and associated connectors should not contact any other conductive parts including earth, as this may increase the risk of harm to the patient or operator.The ifu advises the user that some equipment and/ or techniques fall outside the intended use of standard electrosurgery dispersive electrodes, such as application of high current, long activation times, or use of conductive fluid (e.G.Tissue ablation, joint ablation, etc.).In these high current procedures, there is a risk that excess heat may build up in standard dispersive electrodes which may result in patient injury or burns.Conmed surefit dual dispersive electrodes have not been tested for use during high current procedures and are not recommended for non-standard electrosurgical applications.It also indictaed to consult the generator and accessory manuals for recommendations provided by the manufacturer.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SUREFIT CORDLESS DUAL FOIL PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 11096576
• MDR Text Key: 224525470
• Report Number: 3007305485-2020-00559
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Catalogue Number: 410-2200
• Device Lot Number: 202005044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 01/28/2021
• Patient Sequence Number: 1
• Treatment: SYSTEM 2450 UNKN SERIAL #; T229 REUSABLE CORD, UNKNOWN SERIAL NUMBER
• Patient Outcome(s): Other
• Patient Age: 38 YR