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

Model Number	TX30B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure staple line was incomplete after stapler fired.Doctor used suture reinforcement to complete the case.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/11/2020.D4: batch # t5cp29.Device analysis: the analysis results showed that the tx30b device arrived with no apparent damaged and with a reload loaded on the device.The reload was received fully fired.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 met the staple form release criteria a manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.The event described could not be confirmed as the device performed without any difficulties noted.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10058628
• Report Number: 3005075853-2020-02602
• Device Sequence Number: 14292256
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 05/01/2024
• Device Model Number: TX30B
• Device Catalogue Number: TX30B
• Device Lot Number: T40L2G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/11/2020
• Patient Sequence Number: 1