MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number	TX30G
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	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/13/2024 d4 batch # unk d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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.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 the packaging was opened, the paper immediately pulled open in an unusual manner to unsterilized the device.Another device was used.The issue was noticed at the opening of the blister of the impacted device.The paper part was badly torn/peeled and compromised the sterility of the device.No patient consequence.Use of another device to complete the procedure.No picture available.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/20/2024.Corrected data d4: udi#.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: 9/5/2024.D4: batch #854c57.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 tx30g device was returned inside its original package.Upon visual inspection, it was noted that the tyvek has adhered to the blister in the easy opening area.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number 854c57, 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: 19973159
• Report Number: 3005075853-2024-05933
• Device Sequence Number: 15215807
• Product Code: GDW
• UDI-Device Identifier: 10705036003328
• UDI-Public: (01)10705036003328(17)290131(10)854C57
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: TX30G
• Device Lot Number: 854C57
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 08/20/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/20/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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