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

Model Number ATS45

Device Problems Defective Component (2292); Misfire (2532); Failure to Form Staple (2579)

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

Event Date 08/02/2016

Event Type  malfunction  

Event Description

Two defective staplers in room.First stapler misfired.Second stapler locked open unable to close to use for procedure.The ats45 that misfired while inside the patient was being used on the appendix.The load misfired and the blade was not able to engage properly.The device was unlocked and removed immediately from the patients abdomen.The device along with the misfired staple load were collected and sequestered.There was no surgical intervention needed to repair any vessel.Two other staplers needed to be opened to complete the procedure.The first new stapler that was opened was locked in the open position and could not be closed to be used for the procedure.Another stapler needed to be opened to complete the procedure.This caused a total of three devices needing to be opened.

• Brand Name: ENDOPATH ETS FLEX 45
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 5920537
• MDR Text Key: 53726721
• Report Number: 5920537
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2016

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: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: ATS45
• Device Lot Number: N4LG12
• Other Device ID Number: 00322
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; OTHER, UNDER GENERAL ANESTHESIA
• Patient Age: 69 YR