MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN BLADE 6.5IN; E-Z CLEAN BLADE 6.5 INCH

Catalog Number 0014

Device Problems Human-Device Interface Problem (2949); Material Integrity Problem (2978)

Patient Problem Burn(s) (1757)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 7/27/2023.Mw (b)(4).Photo analysis: this is an analysis of a set of images submitted for evaluation.Two images were provided by the customer.Thumbnail_image1 shows what appears to be a megadyne electrode tip.Thumbnail_image0 (1) shows damage to the insulation.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.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.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: how many issues are there from this account? please note that two files have been opened due to the original email stating ¿we have one confirmed issue, and possibly others but not enough detail ¿.If possible we need to know the exact number of issues the account has had for each procedure.Please report the exact numbers with the exact issues for each procedure if known.Are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to (b)(6).What is the lot number of the device? how long has the account been using the ez clean blades? does the surgeon believe there is an alleged deficiency to the device that led to patient burn and if so why? 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? what pencil was being used with the blade? what generator was being used? was there any diminished effect of the generator noted during the surgery? what is the age of the patient? how long was the activation time? was anything used (tool or instrument) to change out the electrode? does the or staff routinely use a metal surgical instrument to place a new endofactor? what was the lot number associated with this event rampkq or rdmbra.? does the surgeon follow the stated duty cycle in the ifu that states the device should only be activated for a maximum of 10 seconds, and then allow the device to rest for 30 seconds prior to next activation? was the patient's post operative care altered in any way as the result of the difficulties experienced with the device? additional information received in attached medwatch: prolonged hospitalization: 1.Bilateral augmentation mammoplasty, dual plane, with release of the inferior breast tissue.2.Abdominoplasty.3.Suction assisted lipectomy medial thighs.Lot number : rdmbra.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 bilateral augmentation mammoplasty, dual plane, with release of the inferior breast tissue procedure a long bovie tip was opened onto the surgical field.Upon start of the surgery, the bovie machine was set to cut: 40 and coag: 40.The patient was burned on the right breast incision and the bovie tip seemed to have burned away part of the outer coating of the bovie tip.The use of this tip was immediately discontinued, and dr.Stated he had to change the surgery due to the burn.A new bovie tip was opened for use but was passed off due to the potential of another burn.Per dr.'s operative report: ¿of note, the long insulated bovie tip used for the dissection in the pockets was discovered to have a hole in the insulation.This resulted in skin burns on the inferior portion of the incision on the right breast.The burned skin was able to be excised and the incision closed without incident.¿.

• Brand Name: E-Z CLEAN BLADE 6.5IN
• Type of Device: E-Z CLEAN BLADE 6.5 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 ; * ; 3035526892
• MDR Report Key: 17405587
• MDR Text Key: 319929802
• Report Number: 3005075853-2023-05344
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100141
• UDI-Public: 10614559100141
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0014
• Device Lot Number: RDMBRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 86 KG