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

Catalog Number ATS45

Device Problems Defective Component (2292); Failure to Shut Off (2939)

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

Event Date 11/05/2013

Event Type  malfunction  

Event Description

It was reported that during a cholecystectomy procedure, it was impossible to squeeze the handles.Defective clip: handle is not returned, inability to shut up.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Three attempts were made to obtain additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Just for clarification, did the device not close? please explain what is meant by ¿defective clip?¿ please explain what is meant by, ¿handle is not returned?¿ please explain what is meant by, ¿inability to shut up?¿ the analysis results found that the ats45 device was received with the clamping mechanism damaged and with no reload loaded in the device.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the yoke teeth were found broken.While no conclusion could be reached on what caused the clamping mechanism to fail, it is possible that the device was attempted to fire on thicker tissue then indicated or attempted to fire trough a locked reload in previous firings causing an increase of the internal forces resulting in the component yielding.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the required specifications; in addition, a sample of the batch is inspected at (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of the device.

• Brand Name: 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: 3875191
• MDR Text Key: 4461435
• Report Number: 3005075853-2014-04024
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/27/2014

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: 06/12/2018
• Device Catalogue Number: ATS45
• Device Lot Number: 44D33J
• Other Device ID Number: BATCH # K5CF9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2013
• 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