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

Catalog Number NTLC75

Device Problems Partial Blockage (1065); Break (1069); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  No Answer Provided  

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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a colectomy procedure, the device was defective.During the procedure the device blocked and by pushing the firing button it broke off.They had to use a like device to complete the procedure.There were no adverse consequence for the patient reported.

Manufacturer Narrative

(b)(4).Batch # n55u0y.The analysis results found that the ntlc75 device was received with the firing mechanism damaged as the firing knob was detached and the slip block assembly was noted to be damaged.The device was received with one reload present.The reload was returned with the proximal 46 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position, which indicates that the device's firing cycle was interrupted.The damage to the firing knob and slip block assembly is consistent with high (outside indicated use) staple forming forces; however there is insufficient evidence to determine the cause of the higher loads.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.If enough force is applied the device could be damaged.In addition failure to complete the stroke may result in incomplete staple line.For additional information please refer to the instructions for use.Due to the condition of the device, no functional test could be performed with it.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 6176893
• MDR Text Key: 62750183
• Report Number: 3005075853-2016-07058
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/06/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Catalogue Number: NTLC75
• Device Lot Number: N4M63J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1