MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 75 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE

Catalog Number SR75

Device Problems Failure to Advance (2524); Firing Problem (4011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Month and day unknown.Only year (2018) is known.Batch # r58t7j.Device evaluation summary: the analysis found that one sr75 reload was returned with the knife exposed and the proximal 2 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position.The cartridge reload swing tab was reset in order to fire the cartridge.The cartridge was tested for functionality with a test device and fired without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper shape.A probable cause for the reported incident is the device may have been partially fired causing the lockout to be set.Reference ¿instructions for use¿ for complete firing instructions.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that in the course of a right hemi-"coloectomy" procedure using the ntlc, an error occurred in the process of firing.The blade suddenly stopped in the middle of the device, and the blade didn't move forward.As an emergency measure, the surgeon backed off the firing knob and detach it from the tissue.He changed a new cartridge and finished the procedure.There were no reported adverse consequences for the patient so far.

• Brand Name: 75 MM NTLC SELECTABLE RELOAD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8275506
• MDR Text Key: 134093062
• Report Number: 3005075853-2019-16133
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036002833
• UDI-Public: 10705036002833
• Combination Product (y/n): N
• 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
• Report Date: 10/18/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Catalogue Number: SR75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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