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); Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/28/2024.D4 batch # unk.B3: only event year known: 2024.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: 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: 3/8/2024.Additional information received: the severity of the burn is second and third degree in some places.She received burn/wound care outside of our surgical center as well as additional follow up with the surgeon.She has some scarring due to the burn.The long term effect will be scarring.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a malfunction, and has been revised to a serious injury.H1, b1, b2.

Manufacturer Narrative

(b)(4).Date sent: 4/4/2024 the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• 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: 18798067
• MDR Text Key: 336572260
• Report Number: 3005075853-2024-01707
• 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,Followup
• Report Date: 04/04/2024

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0012M
• Device Lot Number: TCMDBX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention