MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Catalog Number 0012M

Device Problems Arcing of Electrodes (2289); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 2/28/2024.D4 batch # unk.B3: only event year known: 2024.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: 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? 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 a breast augmentation that the device is arching a flame that burned the patients nipple.Degree of burn was not specified but healthcare professional indicated that it was a "pretty significant burn".Treatment of the burn was not provided.

Manufacturer Narrative

(b)(4).Date sent: 3/27/2024.Additional information was requested, and the following was obtained: would your account like to have a call with ethicon concerning these issues? if yes, please reply with 3 days and times est that would work.Are there photos that could be shared of the burn? if yes, please share to (b)(6).Was there any treatment for this second-degree burn? if yes, what were they? did the arcing come from the exposed blade portion? or an area of the device more proximal? any damaged noted to the insulation of the device? was it confirmed that the electrode was competed seated in the pencil and no exposed metal at the proximal end? what pencil was this used with? any photos of the device, is yes please send to (b)(6).If the blade was inserted into the pencil, did the or staff use any metal instruments to insert the blade or did they used their fingers? what were the modes of the generator? what was the generator used? was the power level used while the device was activated? was there any additional metal instrument around the nipple that incentivized the electrical current pathway? will the blade that was used for this procedure be returning for analysis? answer: was a small second degree burn that did not require any further treatment.There was no treatment required for the burn.The arcing was noted to come from the connection between the bovie tip and the pencil.The bovie tip was placed by the tech and used her fingers to place it.It was seated properly.Once the arcing was noted and instrument was used to remove the instrument and it was replaced and there was no compromise of the insulation noted.We used the megadyne generator on a setting of cut 35 coag 35.The only other instrument on the field at the time was an addson that was not in contact with the cautery.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the packaging of the 0012m device was returned, and no electrode was returned.Analysis does not confirm (verify) the reported failure.No further investigation will be conducted on this complaint.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Type of Device: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY INDEPENDENCIA; chihuahua ; MX
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18798362
• MDR Text Key: 337068499
• Report Number: 3005075853-2024-01709
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0012M
• Device Lot Number: TCMDBX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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