MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE ACE BLADE 700 ZIP E; MEGADYNE ACE 700 ZIP PEN E CONNECTOR

Catalog Number ME7251E

Device Problems Arcing of Electrodes (2289); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported that during the male to female gender confirmation surgery, the doctor experienced a malfunction with the device.Two minutes in case he was using coag and the tip turned red hot and began to melt.He had been using the flat part of the blade and the arching coming from the edges and the device lit up and melted.There was some retained product in the patient, but he was able to remove the bovi tip from the device and replace it with a 0012 tip which he used to remove the retained product from the patient and finished he case with no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 7/25/2023.B3: unknown, assumed 1st month of the year that the event took place.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: were any fragments generated and fell off inside the patient due this issue? if yes, they were completely removed from the patient without additional intervention? 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.

• Brand Name: MEGADYNE ACE BLADE 700 ZIP E
• Type of Device: MEGADYNE ACE 700 ZIP PEN E CONNECTOR
• 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: 17388143
• MDR Text Key: 320225327
• Report Number: 1721194-2023-00098
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105665
• UDI-Public: 10614559105665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ME7251E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1