MAUDE Adverse Event Report: ETHICON STAPLER

Model Number EL5ML

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 05/03/2016

Event Type  malfunction  

Event Description

The staples would not release on the endoscopic clip applier.

• Brand Name: ETHICON STAPLER
• Type of Device: STAPLER
• MDR Report Key: 5652258
• MDR Text Key: 45285907
• Report Number: MW5062231
• Device Sequence Number: 0
• Product Code: FZP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Lot Number: M4J91U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR