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

Model Number VH-3200

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/23/2023

Event Type  malfunction  

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 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.

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 Description

N/a.

• Brand Name: VASOVIEW 7XB
• 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: 18132749
• MDR Text Key: 328278527
• Report Number: 2242352-2023-00933
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1