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

Catalog Number	TL90
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that during a hartman procedure, after the machine had been fired, half of the staple line had the staples open.The staples were open in half of the staple line.Suture was used to address the issue.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch # p56r0c.Device evaluation summary: the analysis results showed that the tl90 device arrived with no apparent damage with a reload loaded on the device.The reload was returned void of staples.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The device fired without any difficulties and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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: 8354415
• Report Number: 3005075853-2019-16724
• Device Sequence Number: 13959226
• Product Code: GDW
• UDI-Device Identifier: 10705036013198
• UDI-Public: 10705036013198
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 04/24/2022
• Device Catalogue Number: TL90
• Device Lot Number: P92M04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1