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

Model Number	VH-3000-W
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Peeled/Delaminated (1454); Self-Activation or Keying (1557); Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device not returned.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro (ous) vh-3000, when using the trigger button is not pressed, the automatic heating and burning, the machine also continues to make a working sound, the pliers head appears red, hot, and smoking short circuit performance, after shutdown.They found the forceps end line is exposed, debris falls out, laparoscopic acquisition of the great saphenous vein in order to collect the bridge vessels, as much as possible to protect the venous bridge, due to instrument failure, continuous high temperature, forceps hair hot hair scalding, burning the bridge blood vessels, affecting the function of blood vessels, and delaying the process of surgery.The jaws were not open during insertion.No resistance was noted.The power setting was as usual.No additional incisions or procedures were required.Changing the power cords and adaptor cables did not resolve the issue.In view of potential damage to the vein and the patient, the harvester abandoned the device and used new hemopro device to complete the procedure.The affected device was not used for vein harvesting.The device failed before it insert to the cannulation.When it connected to the power supply, it burned and be hot automatically.No other intervention was required.The patient is out of the hospital and in good condition.There was no harm reported to the patient other than a few minutes of delay to swap the device to complete the operation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Corrected section: h6- medical device ¿ problem code (2)- removed code- "1198", h6- removed code -"2930", code added "1557- device remains activated", remaining code from initial- "1454-peeled".The lot # 3000274687 history record review was completed.There were two (02) 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, OUS
• Common Device Name: 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: 17248503
• Report Number: 2242352-2023-00534
• Device Sequence Number: 4834205
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: VH-3000-W
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 3000274687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.; UNKNOWN.
• Patient Age: 71 YR
• Patient Sex: Female