MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN NEEDLE MOD 4.0IN; E-Z CLEAN NEEDLE MODIFIED 4.0 INCH

Catalog Number 0016AM

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that during an unknown procedure causing a burn on patient lip.Generator used is megapower model 1000 sn (b)(6) at setting 25 (coag).Patient has visible burn that may/may not require subsequent treatment.

Manufacturer Narrative

(b)(4), date sent: 2/22/2024.D4 batch # unk.B3: only event year known: 2024.Photo analysis: two photos of a patient¿s oral surgery associated with (b)(4) were evaluated.On both photos, there is a spot of burn injury located slightly insider of the patient¿s left lower lip near left oral commissure.The burn is about round in shape with central tissue showing charring surrounded by a pale ring.The appearance of the burn looks like second degree in severity.The alleged device involved was e-z clean needle mod 4.0in, which has a shapely pointed tip.The burn injury size and shape is not consistent with the device configuration, leading to question what other instrument(s) might be used in the procedure and if that had played a role.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 metal instrument used to change the bovie tips? is there any damage(s) noted on the devices? if yes, where are they and what is the description of the damage(s)? are there photos that can be shared of the devices? if yes, please send to productcomplaint1@its.Jnj.Com.Does the surgeon believe there is an alleged deficiency to the device that led to patient burn and if so why? when were the burns first noticed? what is the severity of the burn? (please see degrees of burns below and choose one) 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 second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful third degree burn ,the burn site looks deep, whitening or blackened and charred.What medical intervention was used to treat the burn (such as salve or stitches)? besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the patient? what was the surgical procedure? what was the surgical procedure date? how long did the surgical procedure last? was there any diminished effect of the generator noted during the surgery? what monopolar disposables were used during the procedure? additional information received: there is a metal retractor in the patients mouth not sure on what order everything goes into the patient¿s mouth.The or director made it a firm statement there was nothing metal that exchange the tip into the pencil only a hand was used.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: 3/6/2024 investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0016m device was returned with a hole in the blue insulation exposing the metal substrate to melting around the edges and blackened in color.Also, it was observed dents like a hole along the length of the blue insulation.It is possible that the observed damage may have affected the functionality of the device.However, no conclusion could be reached as to the cause of the reported event.

Manufacturer Narrative

(b)(4).Date sent: 2/28/2024 additional information was requested, and the following was obtained: were any metal instrument used to change the bovie tips?no.Scrub tech confirmed only fingers (gloved) used.Is there any damage(s) noted on the devices? if yes, where are they and what is the description of the damage(s)?yes- black circular mark on shaft of instrument where burn took place are there photos that can be shared of the devices? device has been returned and photos of injury have been submitted.If yes, please send to (b)(6).Does the surgeon believe there is an alleged deficiency to the device that led to patient burn and if so why? yes- the surgeon believes the device is to blame for the patient injury.When were the burns first noticed? at the time of the injury- intraoperatively what is the severity of the burn? (please see degrees of burns below and choose one) 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 second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful third degree burn the burn site looks deep, whitening or blackened and charre this is a medical diagnosis i am not qualified to make- surgeon also did not comment on this what medical intervention was used to treat the burn (such as salve or stitches)? not known besides the burn, did the patient experience any adverse consequence due to the issue? not known are there any anticipated long-term effects from the burn or injury? not known what is the current status of the patient? not known what was the surgical procedure? tonsillectomy what was the surgical procedure date? how long did the surgical procedure last? was there any diminished effect of the generator noted during the surgery? no but the scrub tech noticed that the distal end of 0037h closest to where it attaches to the 0016am was warm to the touch what monopolar disposables were used during the procedure? all pieces were included in report and returned for analysis.

Manufacturer Narrative

(b)(4).Date sent: 5/9/2024.Investigation summary: the device was sent for further analysis and confirmed the observed damage.The investigation found that a probable cause of the pin-mark damage is from other needle electrodes during the manufacturing process.

• Brand Name: E-Z CLEAN NEEDLE MOD 4.0IN
• Type of Device: E-Z CLEAN NEEDLE MODIFIED 4.0 INCH
• 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 ; PR ; 3035526892
• MDR Report Key: 18760077
• MDR Text Key: 336054784
• Report Number: 1721194-2024-00022
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081791
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0016AM
• Device Lot Number: TDMKEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention