MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN NEEDLE MOD 2.75IN; E-Z CLEAN NEEDLE MODIFIED 2.75 INCH

Model Number 0013M

Device Problems Arcing of Electrodes (2289); Human-Device Interface Problem (2949)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure a spark occurred during surgery at the site of damage to the outer surface of the electrode.Burns to the patient's skin the surgery was delayed 30 minutes to stop and replace the electrode.The procedure was successfully completed.The patient suffered from a burn.

Manufacturer Narrative

Pc-(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.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what is the severity of the burn? first degree what medical intervention was used to treat the burn? (such as salve or stitches) unverifiable.Besides the burn, did the patient experience any adverse consequence due to the issue? no issue are there any anticipated long-term effects from the burn or injury? i heard there were patient complaints of burn rather than health issues.What is the current patient status.Receiving outpatient treatment.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.

Manufacturer Narrative

(b)(4).Date sent: 12/6/2022.

Manufacturer Narrative

(b)(4).Date sent: 12/28/2022 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 0013m device was returned with the insulation and coating damaged.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.It is possible that this damage is caused by the electrode 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 burn to the patient.The instructions for use instruct the user to discard damaged electrodes.Occasionally, damage to the coating occurs when the blade is exposed to metal contact and/or high heat/prolonged activations without tissue.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: E-Z CLEAN NEEDLE MOD 2.75IN
• Type of Device: E-Z CLEAN NEEDLE MODIFIED 2.75 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: 15758887
• MDR Text Key: 307672756
• Report Number: 3005075853-2022-07690
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100134
• UDI-Public: 10614559100134
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0013M
• Device Catalogue Number: 0013M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1