MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS FLEX ARTICULATING LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The analysis results found that the ats45 device was received in good visual condition and with no cartridge reload present.The reload was received fully fired and in good visual conditions.The device was tested for functionality with a test reload and it fired, cut without any difficulties, the staple line was complete, the cut line was complete and the staples were noted to have the proper b-formed shape.The reported event could not be confirmed as the device was received out of its sterile package.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during an unknown procedure, there was a torn "tyvek" on packaging.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: ETS FLEX ARTICULATING LINEAR CUTTER
• 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: 5159998
• MDR Text Key: 28931637
• Report Number: 3005075853-2015-06642
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: ATS45
• Device Lot Number: M4HL64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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