MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN BLADE 4.0IN; E-Z CLEAN BLADE 4.0 INCH

Model Number 0014A

Device Problems Arcing of Electrodes (2289); Human-Device Interface Problem (2949); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of 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? what is the current patient status? 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.7.Remedial action initiated other type 2nd.

Event Description

It was reported that during a mastectomy, in normal practice, the surgeon began to use megadyne hand control with ez clean blade 0014a with coagulation in spray mode.The generator is ft10 valleylab, power setting of spray mode = 40 watts.After activating coag button for 5 minutes, it occurred spark fires burning at the plastic insulation which covered over the 0014a blade.Or team tried to adjust the power setting to be lower, but the fired and burn still appeared.So they stopped and after turning to use another blade, everything went normally and no fires sparking anymore.The surgery was completed successfully.The patient suffered from an unintended thermal damage at muscle layer of skin.

Manufacturer Narrative

(b)(4).Date sent: 9/21/2022.

Manufacturer Narrative

(b)(4) date sent: 8/10/2022 photo analysis: this is an analysis of a set of images submitted to ethicon endo-surgery for evaluation.Image (b08b0b148d9f.Jpeg): the image provided by the customer show two packaging tyvek.The lots can be seen as 206453 and 204570.Image (d1601880fe00.Jpeg): the image provided by the customer shows an electrode tip with a burn mark on the insulation.Image (cd34dd43ef26.Jpeg): the image provided by the customer shows an electrode tip with a burn mark on the insulation.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.Additional information was requested, and the following was obtained: what is the severity of the burn? ans: first degree : no serious complications for this patient, just a few point of muscle burn.Surgeon and or team considered and evaluated as it can be acceptable.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 patient status? ans :it caused a bit longer operation time to solve this fire spark and change to the new blade while running the surgery.But no longer hospital stay and no intervention or medication required for this case.Additional information was requested, and the following was obtained: what pencil was used for the procedure (product code please)? was the blade that was used in the pencil the original blade or was the blade replaced? if it is not the original blade in the pencil what was used to put the blade on the pencil (example a hemostat, etc.)? are there any photos that can be sent of the burn, if yes, please send to (b)(6) answer = for the pencil surgeon used in that case is hua tong disposable electrosurgical pencil as picture attached.And the original blade is removed, then replaced by megadyne 0014a blade which i've reported fired and burnt.In that case, i got the further information that surgeon decided to resolve this incident by using the insulation sterilized tape covering along 0014a where occur fires spark, it's able to protect heat and thermal damage spreading to unintended areas well.And sorry for inconvenience that they didn't take any occurrence of patient burn.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury, and has been revised to a malfunction.H1 b1 (is adverse event) and b2.

Manufacturer Narrative

(b)(4) date sent: 10/6/2022 investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0014a device was returned with insulation and coating damage.Upon visual inspection, it was noticed that the electrode had horizontal scratches as if it had been scrubbed with a metal pad, the instrument was tested for continuity and passed the test.During the visual examination, a hole was found in the blue insulation exposing the metal substrate with melting around the edges and blackened in color.Also observed along the length of the blue insulation are indentations and other surface markings/scratches indicating that the electrode has come in contact with instrumentation.The likely cause of the damage is the electrode was in contact with other instruments and likely was grasped with another instrument (i.E.Hemostats).The evidence suggests that the current strayed from the larger damaged area on the electrode, evident by the characteristics of being blackened and melted, which resulted in the event reported.The instructions for use instruct the user to discard damaged electrodes.The observed damage to the electrode coating may have been caused by a cleaning process.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 4.0IN
• Type of Device: E-Z CLEAN BLADE 4.0 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15092308
• MDR Text Key: 296472874
• Report Number: 3005075853-2022-04787
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100158
• UDI-Public: 10614559100158
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K081791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0014A
• Device Catalogue Number: 0014A
• Device Lot Number: 206453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention