MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER 1000 A GENERATOR; MEGA POWER 1000 A, GENERATOR

Model Number 1000

Device Problems Self-Activation or Keying (1557); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary 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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.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.

Event Description

It was reported that during an unknown procedure that surgeon engaged activation but when activation was stopped the unit continued to supply power.Unknown as to how the procedure was completed.Patient damage occurred but unknown as to the extent of damage.

Manufacturer Narrative

(b)(4).Date sent: 2/7/2023.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: is there any more information on how the patient was damaged? patient suffered burns to the abdomen.One of the burns was a third degree burn.How was the patient damaged? the esu was laid on the drape that was on the patient.The esu then burned through the drape to burn the patient's skin.Did the patient have to undergo any additional surgical procedures or lengthy stays in the hospital due to the event? one additional day in hospital to have wound checks by wound care team.What is the current status of the patient? unknown as patient did not attend her follow up wound care appointment.What was the procedure? patient was undergoing a c-section procedure.Is the unit currently being used in the facility.No, was taken out of service after incident.If no, why not? it was taken out of service pending the outcome of this investigation.Are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com.When were the burns first noticed? immediately.Besides the burn, did the patient experience any adverse consequence due to the issue? no.Are there any anticipated long-term effects from the burn or injury? scarring in the area of the burn.Does the surgeon believe there is there an alleged deficiency to the unit that led to patient burn and if so why? yes the surgeon believes that the esu unit malfunctioned and turned on, on it's own.What power levels was generator set to? unsure.What is the serial number of the generator? the one listed in the complaint doesn¿t look correct.Serial number (b)(6).Was activation with the pencil or a footswitch? footswitch.What pencil was being used? serial number 51603001 esu stryker neptune smoke evacuation pencil.Will the generator and any accessories (ex.Footswitch) be returned? unsure.Will the end factor be returning? unsure.

Manufacturer Narrative

(b)(4).Date sent: 2/13/2023.Photo analysis: this is an analysis of a set of images submitted for evaluation.Two tiny photos associated with (b)(4) are submitted for evaluation.There is no info as to when the photos were taken for what anatomic locations but according to additional event information, the photos are likely representing abdomen and the two photos are not same area.In the photo labelled as (b)(4) pic 1, there is a one main area of skin blackening and two additional skin burn marks.There is also some skin redness visible in the affected area.The skin injury appears to be 2nd to 3rd degree of burn.The shape of the skin burn appears to correspond to the electrode configuration as described in the event description.In the another photo labelled as (b)(4) pic 2, there were three skin blacken burn spots visible.Due to poor resolution, no other apparent skin change can be certain.The skin burn appears to be at least 2nd degree burn.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

• Brand Name: MEGAPOWER 1000 A GENERATOR
• Type of Device: MEGA POWER 1000 A, GENERATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16194241
• MDR Text Key: 307595799
• Report Number: 1721194-2023-00009
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103715
• UDI-Public: 10614559103715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

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 Model Number: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/23/2023; 02/10/2023
• Supplement Dates FDA Received: 02/07/2023; 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1