MAUDE Adverse Event Report: COVIDIEN MULTIFIRE ENDO GIA; STAPLER, SURGICAL

Catalog Number 030811

Device Problems Sticking (1597); Failure to Fire (2610)

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

Event Date 07/28/2016

Event Type  malfunction  

Event Description

The latch was sticking, it would not fire on a multifire endo device.

• Brand Name: MULTIFIRE ENDO GIA
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6185121
• MDR Text Key: 62716808
• Report Number: 6185121
• 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: 11/18/2016,11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 030811
• Device Lot Number: PSL0259X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2016
• 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: 10 YR