MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Intermittent Continuity (1121)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 had intermittent power.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 12apr2021.An investigation was conducted on 01june2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The heater wire was observed to be slightly flexed away at the center of the hot jaw, but remained attached at the base and tip of the hot jaw.The silicone insulation was observed to be intact, no visual defects were observed.A pre-cautery test was performed per the instruction for use (ifu cv000006999) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it did produce visible steam during several activations over a period of 10 minutes but shut off when the toggle was released.The pre-cautery test was repeated 5 times while the cable connections were manipulated with the no failure observed.Based on the returned condition of the device and the evaluation results, the reported complaint for failure "intermittent continuity" was not confirmed.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 11752696
• MDR Text Key: 248208105
• Report Number: 2242352-2021-00329
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25156354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 06/02/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 82