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

Catalog Number	TLH30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent: (b)(6) 2018.Batch # p56f1p device evaluation: the analysis results showed that the tlh30 device was received sterile, with no apparent damaged and with a reload loose inside the sterile package.The device was opened and the reload was loaded into the device, the reload clicked into place, the device was turned upside down and tapped; the reload did not fall out.The device was tested for functionality with the returned reload 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 opened and closed as intended.Although no conclusion could be reached on what caused the reload to eject from the device, it is possible that the package was submitted to higher forces then normal during transportation allowing the cartridge to disengage from the device.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the require specifications.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: when the jaw could not be opened, was the device stuck on tissue? unknown.If yes, how was the device removed from the tissue? unknown.Were the device jaws eventually able to be opened? yes.
Event or Problem Description
It was reported that the jaw could not open.During the lobectomy, could not open the jaw.Customer can't remember how to open the jaw at last.Another device was used to complete the surgery.There were no adverse consequences to the patient.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8056252
• Report Number: 3005075853-2018-14309
• Device Sequence Number: 1953074
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• 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
• Report Date (Section B): 09/19/2018

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: 03/30/2022
• Device Catalogue Number: TLH30
• Device Lot Number: P4T228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1