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

Model Number	0014A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during or set up customer noticed that the product code on the packaging was not the product inside the package.Package was labeled for a four-inch extended blade electrode but inside the package is a six- or six-and-a-half-inch extended blade electrode.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the 0014a device (i) was received inside its sterile package.Upon visual inspection, it was noted that the label is for a 0014a e-z clean blade 4.0 inch; however, inside it has a 6.5-inch e-z clean blade.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.This defect has been correlated to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.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.

• Brand Name: E-Z CLEAN BLADE 4.0IN
• Common Device Name: E-Z CLEAN BLADE 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 ; * ; 3035526892
• MDR Report Key: 16537560
• Report Number: 3005075853-2023-01514
• Device Sequence Number: 15034109
• Product Code: GEI
• UDI-Device Identifier: 10614559100158
• UDI-Public: 10614559100158
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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 Expiration Date: 04/30/2026
• Device Model Number: 0014A
• Device Catalogue Number: 0014A
• Device Lot Number: REMJJQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown