MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH90
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.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.Event month and day unknown.Only year (2018) is known.
Event or Problem Description
It was reported that during a partial open gastrectomy procedure the device was placed on tissue, fired, but staples were unformed, goal post.Towards the base of the anvil they were partially formed.The procedure was completed by suturing the tissue.It was unknown if the staples had been removed.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # n55z7e.Device evaluation: the analysis results showed that the tlh90 device arrived with no apparent damage and with a reload present.The reload was received fully fired.The device was tested for functionality with a test reload trh90 and it fired and formed all the staples as intended.The device fired without any difficulties, the staples were noted to have a proper b-formation and the staple line was complete.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: 7286037
• Report Number: 3005075853-2018-08118
• Device Sequence Number: 2248475
• Product Code: GDW
• UDI-Device Identifier: 20705036013249
• UDI-Public: 20705036013249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 07/17/2021
• Device Catalogue Number: TLH90
• Device Lot Number: N92T10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1