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

Model Number	TX60G
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5c07e.(b)(4).Device analysis: the analysis results showed that the tx60g device arrived with no apparent damaged and with a reload loaded on the device.The reload was received with all staples present and protruding and the drivers partially advance.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.It should be noted that when manipulating the device only the closing trigger should be grasp until ready to fire the device.Do not grasp the firing trigger before the device is to be fired.If the firing trigger is manipulated it could cause the staples to deploy partially or completely resulting in malformed staples and a premature lockout situation.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a low anterior resection, opened sterile tx60g to use stapler on rectum in anterior resection procedure.Surgeon found that the retaining pin could not push to close it, the retaining pin bounce back to the original position.Surgeon tried to close the closing handle but failed to close.Ended open competitive device because that is the last piece of available tx60g in ot.The staff nurse pass the tx60g to me after wash.After trying for a few times, the retaining pin & closing handle can close and able to fire.Therefore, you may see some part of the stapler has stapler.The surgery was delayed by 15-minutes and successfully completed.There were no patient consequences.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11107957
• Report Number: 3005075853-2021-00001
• Device Sequence Number: 3595377
• 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
• Report Date (Section B): 11/11/2020

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: 02/19/2025
• Device Model Number: TX60G
• Device Catalogue Number: TX60G
• Device Lot Number: U4076D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1