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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that not during a procedure that all the packing and labeling was correct but the incorrect device included.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/14/2023.B3: only event year known: 2023.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Forty electrodes were returned and 13 were sampled for analysis.Visual analysis of the returned sample revealed that the 0014a device (b) 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/15/2023 photo analysis: this is an analysis of an image submitted for evaluation.Image: the image provided by the customer shows a 0014a e-z clean blade 4.0 inch inside of 6.5-inch sterile package.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 the ethicon endo-surgery quality system.

• 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: 17125587
• Report Number: 3005075853-2023-04109
• Device Sequence Number: 7377385
• 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,Followup
• Report Date (Section B): 06/15/2023

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: 05/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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