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

Catalog Number	0014AM
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/13/2024 investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0014am device was returned with a hole 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.Additionally, photos were provided and they showed the condition of the reported event.The likely cause of the damage is the electrode was in contact with other instruments and likely was grasped with another instrument.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.A manufacturing record evaluation was performed for the finished device batch sjmhrq, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent 4/24/2024.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information was requested, and the following was obtained: please clarify, was the "big sprinkle" a spark? was the "sprinkle" a flame? [ans: the big sprinkle was a spark with a light flame].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 or Problem Description
It was reported that during a breast mass excision the dr used the tip (0014am) for lumpectomy for a while, then the insulated part of the tip was touched with the retractor accidently and a big sprinkle resulted and the side of the tip was burnt.After that, they changed to other pieces with another lot number and completed the surgery.Esu power 20 & 25 for cutting & coagulation were used.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/9/2024.

• Brand Name: E-Z CLEAN BLADE MOD 4.0IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 4.0 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: 19172551
• Report Number: 3005075853-2024-03182
• Device Sequence Number: 12599990
• Product Code: GEI
• UDI-Device Identifier: 10614559100165
• UDI-Public: 10614559100165
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0014AM
• Device Lot Number: SJMHRQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 05/09/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/09/2024; 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown