MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-3500

Device Problem Mechanical Problem (1384)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro vh-3500 jaws not opening all the way.New device was gotten out to complete case.No delay in case time.No patient effects.

Manufacturer Narrative

Tw 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

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/20/2024.An investigation was conducted on 02/20/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.The heater wire and gray silicone insulation of the jaws were observed to be intact with no visual defects.A mechanical evaluation was conducted.The blue toggle was manipulated to open and close the jaws.The jaws opened fully when the toggle was slid backward.Based on the returned condition of the device and investigation results, the reported failure "mechanical problem; jaws will not open completely", was not confirmed.The lot # 3000363947 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.

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18851742
• MDR Text Key: 337091902
• Report Number: 2242352-2024-00189
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000363947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 64 KG