MAUDE Adverse Event Report: CORE DYNAMICS, INC. CORE DYNAMICS; STAPLER S-12MM ENTREE

Model Number CD775

Device Problem Mechanical Jam (2983)

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

Event Date 03/21/2015

Event Type  malfunction  

Event Description

Stapler got stuck in disposable cap and had to pall trocar and cap off to remove stapler.

• Brand Name: CORE DYNAMICS
• Type of Device: STAPLER S-12MM ENTREE
• Manufacturer (Section D): CORE DYNAMICS, INC.; 11222 st. john's industrial pk; jacksonville FL 32246
• MDR Report Key: 4724357
• MDR Text Key: 21085399
• Report Number: MW5042210
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD775
• Device Lot Number: 1501261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 30