MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. E-Z CLEAN BLADE 2.5IN; E-Z CLEAN BLADE MODIFIED 2.75 INCH

Model Number	0012AM
Medical Device Problem Codes	Fire (1245); Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, a covidien cautery hand control and e-z clean tip ignited while in use.Per the surgeon, there was an actual flame present.The surgical tech reports no issues with replacing the original tip with an e-z clean tip.No harm to the patient.
Additional Manufacturer Narrative
(b)(4).Unknown, assumed 1st day of month and first month of the year that event took place and unk for year.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.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 was the procedure date for this event? 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: 6/9/2022.Additional information received: the correct product code is 0012.D1, d2a, d3, d4, and g1.

• Brand Name: E-Z CLEAN BLADE 2.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 2.75 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo UT 00969 ; PR 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY INDEPENDENCIA; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo, UT ; * ; 6107428552
• MDR Report Key: 13252381
• Report Number: 1721194-2022-00001
• Device Sequence Number: 11879386
• Product Code: GEI
• UDI-Device Identifier: 10614559100080
• UDI-Public: 10614559100080
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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 Model Number: 0012AM
• Device Catalogue Number: 0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown