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

Model Number	0012
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/29/2022.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 0012 device was received with the electrode tip bent to about 45 degrees and with no apparent damage.There were no anomalies noted with the functionality of the device.The device was disassembled to inspect the internal components, no evidence was found that could have caused the reported activation issues.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: electrodes can be bent up to approximately 60°.The use of instruments to modify the electrode and/or excessive bending could damage the coating, insulation, or electrode.The event described could not be confirmed as the device performed without any difficulties noted.

• Brand Name: E-Z CLEAN BLADE 2.5IN
• Common Device Name: E-Z CLEAN BLADE 2.5 INCH
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR
• MDR Report Key: 15427936
• Report Number: 3005075853-2022-06124
• Device Sequence Number: 12533545
• Product Code: GEI
• UDI-Device Identifier: 10614559100080
• UDI-Public: 10614559100080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 0012
• Device Catalogue Number: 0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown