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

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Intermittent Continuity (1121); Mechanical Problem (1384)

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

Event Date 03/18/2021

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, vasoviewhempro vh-3500 jaw was mal-aligned and did not seal or cauterize tissue -observed right at the beginning as they were trying to use it.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 04/02/2021.An investigation was conducted on 04/05/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Tissue and charred material was observed on the heater wire.Blood was also observed on the jaws.A mechanical evaluation was conducted.The blue toggle was manipulated to open and close the jaws with no physical or visual difficulties.When the jaws were closed, the jaws were aligned properly.An electrical evaluation and testing was conducted.A pre-cautery test was performed per the instruction for use (ifu cv000006799) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam and audible sound during several activations over a period of 10 minutes and shut off when the toggle was released toggle.The pre-cautery test was repeated 10 times with no observed failure.Based on the returned condition of the device, the reported failures "mechanical issue" as well as "intermittent continuity" were not confirmed.The lot # 25153858 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro vh-3500 jaw was mal-aligned and did not seal or cauterize tissue -observed right at the beginning as they were trying to use it.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 11636175
• MDR Text Key: 244638606
• Report Number: 2242352-2021-00265
• 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: 04/08/2021

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 Expiration Date: 09/28/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25153858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/07/2021
• Patient Sequence Number: 1