MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. NON COATED PNCL BTN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number 251010J

Device Problems Flaked (1246); Arcing of Electrodes (2289); Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that during a liver transplant the bovi was activated outside of the patient and a spark jumped off the electrode and ignited a sponge.Attempting to douse the fire the surgeon burned her hand creating a blister.The sponge was thrown to the floor and doused with saline.There were no patient consequences.

Manufacturer Narrative

(b)(4).Only event year known: 2023.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: are there any photos of the burn that you could share with us in regards to the burn?: no pictures available.If yes, please send to (b)(4).What is the severity of the burn?: unknown.What medical intervention was used to treat the burn?: unknown.Are there any anticipated long-term effects from the burn or injury?: unknown.What is the current status of the surgeon?: event took place on a saturday and rep was in a case with the surgeon on the following monday and she made no mention of the burn.In the surgeons opinion what was the contributing factor that caused the spark/fire?: none, everyone seems to be confused as to how it happened.What power levels was generator set to?: set to 60 60.What was the end factor that was being used?: was a megadyne probe but code is unknown.Exact product code for megadyne pencil is unknown at this time.To capture pec's for the pencil the code of 251010j has been assigned.If additional information becomes available at a later time the file will be updated accordingly.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 3/31/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.We received a stainless steel electrode in a plastic bag and surgical gauze, in addition, no pencil was found in the returned sample.Upon visual inspection, it was observed that the electrode was returned with a melted and charred tip.It is possible that this damage was caused by exposing the blade to metal contact and/or prolonged high heat/activations without tissue and may have caused the reported event.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, bhr could not be performed.Additional information provided: the pencil tip that was received for analysis is a new dean product.It could be 0038 electrosurgical pencil, rocker, w/0312 flex tip blade 0038h electrosurgical pencil, rocker, w/holster, w/0312 flex tip blade 0039 electrosurgical pencil, button, w/0312 flex tip blade 0039h electrosurgical pencil, button, w/holster, w/0312 flex tip blade.With the bom the nd product code for the electrode is an internal number at nd g101000 could refer to 0039.D1, d4, d2a, g1.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2023.Additional information was requested, and the following was obtained: was the pencil inspected before use? (e.G.Inspection of packaging, nicks on cable insulation, damage of the active electrode, looseness of the active electrode, cord connection to the generator, esu inspection, etc.) 0yes.0no.Was the defect discovered before or after pencil application to the patient? 0yes.0no.What type of electrolyte irrigation solution was used? 0yes.0no.Was the surgical procedure performed in an oxidizer (oxygen or nitrous oxide) enriched environment? 0yes.0no.Were flammable agents used? 0yes.0no.Were there any bends, kinks, or knots present on the electrosurgical cord at the time of defect discovery? 0yes.0no.Was the pencil tested prior to its application to the patient? 0yes.0no.Type of surgical procedure being performed at the time of defect discovery 0yes.0no.Was the active electrode bent or modified at any time? if yes, was it bent before or during the procedure? 0yes.0no.Was a safety holster used? if yes, where was it located during the procedure? 0yes.0no.What was the duration of the surgical procedure? 0yes.0no.Generator model 0yes.0no.Generator power settings 0yes.0no.Cut: watts; coag: watts is a photo of the affected site available? 0yes.0no.Size of the affected site? 0yes.0no.Answer - no additional information is available.

• Brand Name: NON COATED PNCL BTN
• Type of Device: RETURN ELECTRODE CABLE, DUAL PLATE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16459097
• MDR Text Key: 310412602
• Report Number: 1721194-2023-00051
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100851
• UDI-Public: 10614559100851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965054
• 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,Followup
• Report Date: 04/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 251010J
• Device Catalogue Number: 0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/27/2023; 04/10/2023
• Supplement Dates FDA Received: 03/31/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention