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

Catalog Number NTLC75

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Month and day unknown.Only year (2018) is known.Batch # r58u28.Device evaluation summary: the analysis results found that the ntlc75 instrument was received with no apparent damage with a sr75 cartridge reload present.The cartridge reload had the swing tab in the locked position, and fully loaded with staples.In addition, with the right gripping surface broken off making the reload nonfunctional.The device was tested for functionality with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper shape.It is possible that the damaged on the cartridge was caused when the cartridge was removed from the device.Reference ¿instructions for use¿ for complete loading 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 during pppd procedure, the blade stopped in the jaw and could not proceed toward distal side, so surgeon changed another device and finish the operation.There were no patient consequences reported.

• Brand Name: 75MM SELECTABLE NEW TLC
• 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: 8207950
• MDR Text Key: 132075683
• Report Number: 3005075853-2019-15428
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: 10705036002628
• 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: 09/14/2018

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: 05/06/2023
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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