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

Catalog Number SR75

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r5700r.Device evaluation summary: the analysis results found that a sr75 reload was received with both gripping surface broken off making the reload nonfunctional.No functional testing was performed due to the condition of the reload.The condition on the returned reload is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and proper loading.Please refer instructions for use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, ntlc knife didn't forward.There were no patient consequences reported.

• 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: 9181917
• MDR Text Key: 195587528
• Report Number: 3005075853-2019-22738
• 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: 09/18/2019

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: 12/16/2022
• Device Catalogue Number: SR75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1