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

Catalog Number	0012AM
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an right breast excisional biopsy procedure there was a small fire due to bovie tip.While the surgeon was using the insulated bovi for cautery, it connected with the adson forcep.A spark flew and landed on a nearby raytec.Smoke started to come from the raytec.She grabbed the raytec, placed it on floor and stepped on it to put out.The patient was unharmed.We pulled the bovi tip that was used. .
Additional Manufacturer Narrative
(b)(4).Date sent: 1/30/2024.B3: only event year known: 2024.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 batch.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/12/2024.Investigation summary.The product was returned to for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 0012am device was received with scratches on the insulation and coating.The tip appears to have been used extensively.A continuity test was performed, and no anomalies were noted.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.The most likely cause of the observed damage is that the device may have come into contact with other instruments during the procedure when handling the device or possibly during a cleaning process with a metal pad and this could cause the reported event.A manufacturing record evaluation was performed for the finished device batch tjmemj, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/11/2024.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 0012am device was received with scratches on the insulation and coating.The tip appears to have been used extensively.A continuity test was performed, and no anomalies were noted.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.The most likely cause of the observed damage is that the device may have come into contact with other instruments during the procedure when handling the device or possibly during a cleaning process with a metal pad and this could cause the reported event.

• Brand Name: E-Z CLEAN BLADE MOD 2.75IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 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: 18606677
• Report Number: 3005075853-2024-00825
• Device Sequence Number: 13043565
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2024

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: 0012AM
• Device Lot Number: TJMEMJ
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 04/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/12/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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