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

Model Number 0012M

Device Problem Human-Device Interface Problem (2949)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that back in 2020 that during an excision and biopsy of lesion and removal of impacted wisdom teeth (2) the cautery set at 15 watts was used to separate the tonsil capsule from the muscle on the left side of the mouth.A left oral burn was noted shortly thereafter.A wet gauze was immediately applied.A cautery was used to stop the bleeding.Bacitracin was applied.Physician notified the parents of the incident.No further information was provided.

Manufacturer Narrative

(b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information received: the product used was megadyne 0012m bovie tip in conjunction with medtronic valleylab force triad generator and medtronic e2515h pencil with medtronic e7507 bovie return electrode pad.No lot number was able to be found from children's healthcare for the 0012m bovie tip.Bovie settings coag 12-20, cut 12-20.Cut button was never used, only coag.Bovie pad was affixed to patient's left anterior thigh.Additional information was requested, and the following was obtained: could you please confirm 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 the wound was superficial, and there was no staging of the wound.What medical intervention was used to treat the burn? (such as salve or stitches) bacitracin was applied.The discharge instructions were ¿use/apply bacitracin tonight and tomorrow morning on the burn area.After that you can use aquaphor 3 times a day.You can apply more aquaphor anytime wound is dry and not moist." bacitracin was applied.On (b)(6) 2022 the family consulted plastics.Plastics stated that no acute interventions were recommended at that time.Plastics note states, ¿though patient is poorly compliant with exam, 1.5 cm rope-like scar is palpated in the mucosal tissues of the left oral commissure.There is evidence of minimal involvement of scarring without significant hypertrophy at the left commissure itself.He seems to be able to control his oral secretions on exam today.He does not have significant asymmetry on repose and some slight commissural contour abnormalities on animation.From what i can see his incisal opening is not significantly limited by this.¿ besides the burn, did the patient experience any adverse consequence due to the issue? possible feeding aversions due to scar.Are there any anticipated long-term effects from the burn or injury? none.What is the current status of the affected (patient or user)? small aesthetic white burn line on patient's lower lip.Was there any noted damaged on any of the devices? no damage was noted on any of the devices.Does the surgeon believe there was any alleged deficiency with the device and if yes what were they? i was told by the hospital that the surgeon believes the incident occurred as a result of user error in that the megadyne bovie tip was not fully inserted into the covidien bovie upon assembly by the scrub tech and that this led to the unintentional alternate site burn.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.

• 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
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16904376
• MDR Text Key: 314929208
• Report Number: 3005075853-2023-03208
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0012M
• Device Catalogue Number: 0012M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• 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; Disability