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

Model Number VPX3000

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

Bipolar function would not work.We had to open another venapax to complete the procedure.Product had patient contact but no patient harm.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: 7605438
• MDR Text Key: 111203375
• Report Number: 7605438
• Device Sequence Number: 1
• Product Code: GEI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: VPX3000
• Device Lot Number: 37FG2902
• 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: 05/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• 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
• Treatment: NOT KNOWN.
• Patient Age: 74 YR