MAUDE Adverse Event Report: SAPHENA MEDICAL VENAPAX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VPX3000

Device Problem Device Inoperable (1663)

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

Event Date 06/13/2018

Event Type  malfunction  

Event Description

Venapax bipolar cautery was not working.A new one had to be opened to complete the procedure.The product had patient contact but no reported harm.The product is available to be returned to the manufacturer.

• Brand Name: VENAPAX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SAPHENA MEDICAL; 375 west street; west bridgewater MA 02379
• MDR Report Key: 7658674
• MDR Text Key: 113055285
• Report Number: 7658674
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPX3000
• Device Lot Number: 37CH0741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Event Location: Operating Room
• Date Report to Manufacturer: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA