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	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the device was to be used at the factory, it was reported that there was a part that it was not sealed because mega chip was caught in the sealed portion of an individual package.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: does the damage to the package compromise the sterility of the device? yes.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: 7/17/2024.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/19/2024.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 0012am device was returned sealed inside its original packaging.Upon visual inspection, it was observed that the tyvek from the packaging was damaged.Additionally, photos were provided and they showed the condition of the reported event.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/13/2024.Investigation summary: this defect has been correlated to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.

• 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 ; 3035526892
• MDR Report Key: 19700770
• Report Number: 3005075853-2024-04950
• Device Sequence Number: 20777406
• Product Code: GEI
• UDI-Device Identifier: 10614559100103
• UDI-Public: 10614559100103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2024

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: UAMPUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 07/18/2024; 08/05/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/17/2024; 07/19/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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