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

Catalog Number	TX30G
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/9/2024 d4: batch # 521c38.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the tx60g device arrived with no apparent damage and with a xr30v reload loaded on the device which caused the instrument to not work correctly.The reload was received fully fired with some malformed staples on the reload deck and it was pulled out of the device and the device was tested for functionality with a test xr30g reload and it fired and formed all the staples as intended.The device fired without any difficulties and the staples meet the staple form release criteria.It should be noted that the tx60g device should not be used with a xr30v (vascular reload) since the vascular reload is not interchangeable with the blue and green reloads.Note: the blue (standard) and green (thick) reloads can be used interchangeably with the appropriately english sized instruments.The white (vascular) reload is dedicated to the 30 mm vascular linear stapler and is not interchangeable with the blue and green reloads.Please reference the instructions for use for the complete guide loading and reloading the instrument.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 521c38, and no non-conformances were identified.The lot#673c13 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
Event or Problem Description
It was reported that during a lung transplant procedure that the device failed.Once locked on tissue the device would not open, forced to manually open the stapler.No further information was provided.Unknown as to how the procedure was completed.There were no adverse consequences for the patient.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 19280448
• Report Number: 3005075853-2024-03518
• Device Sequence Number: 7649064
• Product Code: GDW
• UDI-Device Identifier: 10705036003328
• UDI-Public: 10705036003328
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 521C38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/09/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown