MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number	TLC55
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/19/2024 d4 batch # unk 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 lot.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: was part of the packaging found to be damaged (tyvek, plastic/blister, packaging seal, etc.)? or was there difficulty opening the packaging material (difficulty removing/peeling back the tyvek)? 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.
Event or Problem Description
It was reported that during an unknown procedure when they tried to take the package off, it had ripped, and it made it become deemed unsterile.They got a new device to proceed with no patient complications.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/11/2024.D4: batch #361c62.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 tlc55 device was returned with not apparent damage along with a tyvek.Upon visual inspection, it was noted that the tyvek was returned delaminate.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this lot possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique; however, no conclusion could be reached as to what may have caused this condition.Although no conclusion could be reach on the cause of the reported event of "packaging integrity".It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number 361c62, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20002255
• Report Number: 3005075853-2024-06087
• Device Sequence Number: 4953705
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: (01)10705036013204(17)280229(10)361C62
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: TLC55
• Device Lot Number: 361C62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown