MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3200
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview 7 xb bisector.They opened the vh-3200 (vv7) evh kit on the sterile table during setup in the or before the patient was in the room.They stated the pig tail connector on the vv7 biploar device got caught on the packaging and caused the bipolar device to touch a non sterile surface.A new kit was opened.
Additional Manufacturer Narrative
(b)(4).The lot # 3000321141 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 no specific failure.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW 7XB
• 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: 18132749
• Report Number: 2242352-2023-00933
• Device Sequence Number: 18090243
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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
• Device Expiration Date: 06/06/2025
• Device Model Number: VH-3200
• Device Catalogue Number: VH-3200
• Device Lot Number: 3000321141
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown