MAUDE Adverse Event Report: COVIDIEN ENDO GIA ULTRA UNIVERSAL; STAPLE, IMPLANTABLE

Lot Number P6F0309X/N6H0173UX

Device Problem Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 11/28/2016

Event Type  malfunction  

Event Description

The stapler failed to fire.

• Brand Name: ENDO GIA ULTRA UNIVERSAL
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6085219
• MDR Text Key: 59361140
• Report Number: 6085219
• Device Sequence Number: 1
• Product Code: GAG
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: P6F0309X/N6H0173UX
• Other Device ID Number: 60MM RELOAD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• 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
• Patient Age: 24 YR