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

Model Number	TX60G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported that during an open pneumectomy, when bronchus was set down the instrument did not staple, all staples were unformed.A hand anastomosis was done.No further consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Batch # u5a78x.Device analysis: the product was returned to ethicon endo surgery 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 damaged and with a reload loaded on the device.The reload was received fully fired.In addition, a tyvek was received along with the device.The device was tested for functionality with a test reload 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.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: attempting to force the trigger to complete the closing stroke with too much tissue or thickened tissue may result in poor staple formation with the loss of staple line integrity and subsequent leakage, disruption, or poor healing.In addition, instrument damage or failure may result.The event described could not be confirmed as no malformed staples were observed and the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12259239
• Report Number: 3005075853-2021-04325
• Device Sequence Number: 17098225
• Product Code: GDW
• UDI-Device Identifier: 10705036003359
• UDI-Public: 10705036003359
• Combination Product (Y/N): N
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Expiration Date: 12/25/2024
• Device Model Number: TX60G
• Device Catalogue Number: TX60G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1