MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS FLEX 45MM; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problems Sticking (1597); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Maude report number: mw5070404.As the reporter is listed as anonymous, no follow up for additional information can be performed.

Event Description

It was reported that the physician was using the device to resect part of the liver.The first use, it was put over the part of the liver to be resected, closed the jaws, the stapler would only fire half way.It was described that load only fired halfway across and the blade was sticking up out of the device.The staff reported that they could not get the blade back down or the jaw to close.It is not known how the procedure was completed.There were no adverse patient consequences reported.

• Brand Name: ETS FLEX 45MM
• 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: 6718046
• MDR Text Key: 80401277
• Report Number: 3005075853-2017-03598
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: ATS45
• Device Lot Number: P4R91N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1