MAUDE Adverse Event Report: VITALITEC GEISTER VALVE GATE GRASPER; SURGICAL

Model Number 34-7826

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

Jaws of geister valve gate graper stopped functioning while holding a vent intra-operatively.Physician able to recover vent from heart atrium without incident.

• Brand Name: GEISTER VALVE GATE GRASPER
• Type of Device: SURGICAL
• Manufacturer (Section D): VITALITEC; plymouth MA 02360
• MDR Report Key: 4699149
• MDR Text Key: 5716764
• Report Number: MW5042089
• Device Sequence Number: 1
• Product Code: DWS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 34-7826
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR