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

Catalog Number	TX30B
Medical Device Problem Codes	Difficult to Insert (1316); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/6/2024, d4: batch #279c14.The following information has been requested.To date a response has not been received.Should additional information be received, a supplemental report will be submitted: was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? how was the bleeding controlled? did the patient require a transfusion? could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? investigation summary visual analysis of the returned sample revealed that the tx30b device arrived with no apparent damage and with a incorrect reload xr30v loaded on the device.The reload was received fully fired.The device was tested for functionality with a test reload xr30b and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria as part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.The incorrect cartridge loaded is consistent to an improper use.Please reference the instruction for use for more information: 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.A manufacturing record evaluation was performed for the finished device batch number 279c14, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an unknown surgery the white vascular was difficult to load into the tx30b device.Patient experience 1500 cc blood loss.Surgery was delayed by hours.

• 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 ; * ; 3035526892
• MDR Report Key: 20162787
• Report Number: 3005075853-2024-06640
• Device Sequence Number: 15281881
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: (01)10705036003311(17)280131(10)279C14
• 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
• Report Date (Section B): 09/06/2024

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: TX30B
• Device Lot Number: 279C14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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