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

Catalog Number	TL60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during an open whipple procedure, the device did not staple.There is no further information available about the event.Case completed with another device of the same product code.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # r57u2k.The analysis results showed that the tl60 device was received with the hook shroud opened by the seam and with a cartridge loaded on the device.The cartridge was returned fully loaded with staples.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the device was noted to have the lockout slide tip and the adjusting knob damaged.The damage to the lockout slid tip and knob is consistent with an excessive force applied to the rotating knob when trying to dial down a locked device, causing the damage to the knob.It should be noted that the instrument has been designed with a lockout feature, which during the first application, prevents turning the adjusting knob unless the retaining pin is pushed completely forward.Please reference the instructions for use for additional information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8124799
• Report Number: 3005075853-2018-14761
• Device Sequence Number: 267915
• Product Code: GDW
• UDI-Device Identifier: 10705036013181
• UDI-Public: 10705036013181
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 02/15/2023
• Device Catalogue Number: TL60
• Device Lot Number: R40982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1