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

Catalog Number ATW45

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2015

Event Type  malfunction  

Event Description

It was reported that during an anterior and posterior vaginal repair, suprapubic catheter and tvt tape and check cystoscopy procedure, three devices were opened.The first two were faulty, the third was usable.Ps was not present; ps received an e-mail post-surgery letting her know what had happened.No indication of fault was given; awaiting feedback to identify what "fault" entailed and ps will provide the information.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Information was not provided by the contact.Incomplete cycle, spring lockout tab.Additional information was requested and the following was obtained: what was meant by ¿faulty¿? device wouldn¿t fire; out of box failure.Did the device deliver any staples? device wasn¿t able to be fired at all.If yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? device wasn¿t able to be fired at all if yes, was the cut line complete? on which firing(s) did this event occur (1st, 2nd, 8th, etc.)? 1st.What colour cartridge was being used? white.Was buttressing material utilized? if so, which product? no.Is the instrument fired across or near an existing staple line or clip? no.Were any unexpected noises heard? if so, when? no.Were any of the forces higher or lower than expected (closing or opening)? no.The analysis showed that the atw45 device was received in good visual condition and with a tr45w cartridge loaded in the device.The reload was received partially fired 1/10 and with the reload lock out spring damaged.The damage to the reload lockout spring is consistent with damage observed when the firing cycle is started, interrupted, released, and restarted.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.The returned device was tested for functionality with a test reload and it fired, cut and formed all the staples as intended.The device fired without any difficulties, the staple line was complete and the staples were noted to have the proper b-formed shape.The device history records were reviewed and the manufacturing criteria was met prior to the release of the device.

• Brand Name: ENDOPATH ETS LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4734142
• MDR Text Key: 5771499
• Report Number: 3005075853-2015-02674
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2015

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: 06/18/2019
• Device Catalogue Number: ATW45
• Device Lot Number: L4EZ4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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