MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LINEAR CUTTERS NTLC; STAPLE, IMPLANTABLE

Catalog Number NTLC75

Device Problems Break (1069); Fire (1245); Sticking (1597); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

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.As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported that during an unknown procedure, the gun got stuck during firing.They then replaced the reload.The same thing happened again with the second reload and the firing knob of the device broke during unlocking.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

• Brand Name: LINEAR CUTTERS NTLC
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6555958
• MDR Text Key: 74863576
• Report Number: 3005075853-2017-02462
• Device Sequence Number: 0
• Product Code: GDW
• Reporter Country Code: JO
• PMA/PMN Number: K092577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1