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	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation: the analysis results showed that the tl90 device arrived with no apparent damaged with a trh90 loaded on the device and fully loaded with staples.It should be noted that the reload will only fit and operate properly in the linear stapler for which it has been designed that is the tl90 device will only work with a tr90 reload and a tlh90 device will work with the trh90 reload.For more information please refer to the instructions for use.The device was tested for functionality with a test reload tr90, (b)(4), and it cycled, fired, and all the staples formed as intended.The device fired without any difficulties and the staples were noted to have the proper b-formed shape.The device was disassembled to verify the condition of the internal components and the device was noted to have the lockout tab and the adjusting knob damaged.The damage to the tab 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.
Event or Problem Description
It was reported, that during a bowel anastomosis, when the knob is turned on device, body of stapler splits and breaks.Breakage occurred during case, prior to performing bowel anastomosis.Patients outcome fine.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7110072
• Report Number: 3005075853-2017-06677
• Device Sequence Number: 11107386
• Product Code: GDW
• UDI-Device Identifier: 20705036013195
• UDI-Public: 20705036013195
• 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): 09/13/2017

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: 02/08/2022
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1