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

Lot Number N5F0927KX

Device Problems Crack (1135); Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 09/09/2015

Event Type  malfunction  

Event Description

Stapler would not fire, a crack was heard when the stapler was closed.A new handle was opened and the device still would not fire.A new handle and endo gia was opened and the procedure was resumed without incident.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 5107324
• MDR Text Key: 26896812
• Report Number: 5107324
• Device Sequence Number: 1
• Product Code: GDW
• 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
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Lot Number: N5F0927KX
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• 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: 43 YR
• Patient Weight: 104