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

Catalog Number SR75

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n53l6l.The analysis found that one sr75 reload was received fully loaded with staples, locked and with the "doghouse" component of the cartridge damaged.A probable cause for the damage to the doghouse component indicates that the cartridge reload was improperly loaded (long loaded); then, closing the lever damaged the knife shroud.This may appear as the device not closing.Please reference the ifu for proper cartridge loading.The batch history record was reviewed and no defects, ncrs or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a gastrectomy procedure, the cartridge was defective and the surgeon couldn't close the device to fire.Another like cartridge was used to complete the procedure.There were no adverse consequences for the patient.

• 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: 6089799
• MDR Text Key: 59777551
• Report Number: 3005075853-2016-06410
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2016

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: 02/28/2021
• Device Catalogue Number: SR75
• Device Lot Number: N4L740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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