MAUDE Adverse Event Report: ETHICON-ENDO SURGERY, INC. ETHICON ETS-FLEX ARTICULATING ENDOSCOPIC LINEAR CUTTER

Model Number ATS45

Device Problem Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 05/16/2016

Event Type  Injury  

Event Description

Ethicon ets-flex articulating endoscopic linear cutter only stapled partially.No harm to patient.

• Brand Name: ETHICON ETS-FLEX ARTICULATING ENDOSCOPIC LINEAR CUTTER
• Type of Device: LINEAR CUTTER
• Manufacturer (Section D): ETHICON-ENDO SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 5690801
• MDR Text Key: 46383214
• Report Number: MW5062571
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: ATS45
• Device Lot Number: N4L819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR