MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR; MEGADYNE¿ SMOKE EVACUATOR

Model Number MESE1

Device Problems Arcing at Paddles (1032); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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: per the event description, it¿s stated : ¿right after use when the diathermy tip was not activated, hcp was putting the pencil down when it brushed against her assistant¿s¿ did the device keep continuously activating, without pressing any energy button? hcp is curtained that diathermy tip was not activated and foot pedal was not stepped on.Could you please confirm what is the severity of the burn? (please see degrees of burns below and choose one).I.First degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.Ii.Second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.Iii.Third degree burn the burn site looks deep, whitening or blackened and charred seems like first degree burn.What medical intervention was used to treat the burn? (such as salve or stitches) he was immediately treated by sgh¿s in-house staff clinic physician, blood tests were done to rule out any infectious disease transmitted from patient contact.Checked in with the affected doctor on (b)(6) 2023 and he confirms that he is fine and doing well.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? no effects reported as of yet.What is the current status of the affected (patient or user)? patient and affected doctor is well.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 right after use when the diathermy tip was not activated, hcp was putting the pencil down when it brushed against her assistant¿s gown and burnt through his gown and he suffered minor burns on his forearm.The assistant is now fine, medical treatment was sought immediately.Hcp also mentioned witnessing sparks at the juncture where the diathermy touches the forceps during use.The settings of the esu are as follows: cut 20 and coag 35.

Manufacturer Narrative

Pc-(b)(4).Additional information was requested, and the following was obtained: there was only 1 cautery pencil connected to the generator and that was 251010j.From what i understood (as i was not present in the case), they removed the tip of 251010j and replaced it with 0012am.Hence only 1 monopolar port was used.

Manufacturer Narrative

Pc-(b)(4).Photo analysis: this is an analysis of an image submitted for evaluation.Image: a forearm photo shows a soybean sized skin lesion, which is dry with some redness around.According to the description of the incident, the appearance of the injury is consistent with electric spark skin burn, resembling first or second 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.Additional information was requested, and the following was obtained:.What was the surgical procedure? mastectomy and sentinel lymph node biopsy 2.When it is stated ¿medical treatment was sought immediately¿ what type of medical treatment was given (such as salve or stitches)? wash and simple dressing.No stitches required.3.Does the surgeon believe there is there an alleged deficiency to the ethicon product that led to the burn and if so please describe? yes, they believe that there may be a leakage of current with the machine and have requested to pull the machine out of ot for inspection.Our service engineer has inspected it afterwards and deemed the machine is working within appropriate limits.4.Approximately how long was the pencil activated prior to burning through the gown? approx.1 hour 5.Approximately time the device was allowed to cool prior to touching the gown? approx.2-3 seconds.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: an e-mail mentions that both megadyne¿ smoke evacuation pencils (251010j) & ez-clean blade tip (0012am) were used during the procedure.Were the two cautery pencils connected at the same time to the generator? (what i mean is, were both the monopolar ports a & b being used simultaneously?).Because our ifu recommends only use of one monopolar port at a time.¿ please let us know as soon as possible.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• 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: 16283070
• MDR Text Key: 308621476
• Report Number: 1721194-2023-00036
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2023
• 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
• Patient Outcome(s): Required Intervention