MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 2 W/VASOSHIELD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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.
Event or Problem Description
The hospital reported that during saphenous endoscopic vessel harvesting procedure, vasoview hemopro 2 (w/vasoshield) would stop working in the middle of the ligation process.There was no obvious reason for the overheating safety mechanism to be activated.The generator and all power cords were replaced.Unfortunately, the same problem continued.The power was set to 3.Therefore, the device was deemed unsafe for use and was removed from the surgical field.A new device was opened and the remainder of the case was finished with no other issues.The only surgical delay was the time needed to open up a new kit which was about 3 minutes.No injuries occurred due to the defect.
Additional Manufacturer Narrative
Trackwise id# (b)(4).Updated sections: b-4,g-3, g-6, h-2, h-11.Corrected section:h-3 from "device not returned" to "device discarded".Corrected section:h-6 from "device not returned" to "device discarded".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The lot # 3000422785 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: HEMOPRO 2 W/VASOSHIELD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 20688985
• Report Number: 2242352-2024-0001242
• Device Sequence Number: 7197128
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000422785(17)260921
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2024

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: 09/21/2026
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000422785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/21/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/15/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2024
• 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: GENERATOR, POWER CORDS
• Patient Sex: Unknown