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

Catalog Number ATS45

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # m54g3w.Firing trigger, incomplete cycle, spring lockout tab.Additional information: the device locked out when the firing trigger broke; a few staples were pushed up, but no staples deployed into the tissue and the device did not cut.The analysis results found that the ats45 device was received with the firing trigger damaged and with a tr45w cartridge loaded in the device.The returned reload was partially fired 1/10 which indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during a laparoscopic vaginal hysterectomy (lvh) procedure, the surgeon closed the device with closing trigger and when firing the grey firing trigger the handle cracked off.A few staples were deployed.The stapler was removed and discarded.A white reload was being used.A new stapler was introduced and procedure was completed successfully.There were no adverse consequences for the patient.

• 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: 5159513
• MDR Text Key: 28838263
• Report Number: 3005075853-2015-06637
• 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
• Report Date: 08/31/2015

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: 06/13/2020
• Device Catalogue Number: ATS45
• Device Lot Number: M4HW6U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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