MAUDE Adverse Event Report: COVIDIEN; STAPLER

Lot Number J2J020

Device Problems Break (1069); Detachment Of Device Component (1104); Misfire (2532)

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

Event Date 02/11/2013

Event Type  malfunction  

Event Description

Two skin staplers misfired as being used.Staples not discharged.One stapler had a piece broken off during discharge.

• Type of Device: STAPLER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street ; mansfield MA 02048
• MDR Report Key: 4549274
• MDR Text Key: 21091077
• Report Number: 4549274
• Device Sequence Number: 1
• Product Code: GDT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: J2J020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Patient Sequence Number: 1
• Patient Age: 32 YR