MAUDE Adverse Event Report: ETHICON ENDO - SURGERY ENDOPATH EMS 5.3MM X 3.7MM - 10/11MM; MULTIFEED STAPLER - 20

Model Number EMS

Device Problem Failure to Discharge (1169)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

Ethicon endo-surgery one endopath ems multifeed stapler - 20 would not discharge its staples.Diagnosis or reason for use: laparoscopic robotic sleeve gastrectomy.

• Brand Name: ENDOPATH EMS 5.3MM X 3.7MM - 10/11MM
• Type of Device: MULTIFEED STAPLER - 20
• Manufacturer (Section D): ETHICON ENDO - SURGERY; guaynabo PR 00969
• MDR Report Key: 3639670
• MDR Text Key: 17614114
• Report Number: MW5034619
• Device Sequence Number: 1
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: EMS
• Device Catalogue Number: EMS
• Device Lot Number: K92A4Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR