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

Model Number	VH-3200
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise 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 or Problem Description
The hospital reported that the vasoview 7 xb bisector (us), access port for co2 was blocked.It was discovered when hooking up to the co2.No sign of physical damage or degradation on the co2 access port was reported.They took the hand piece, and found out is also had co2 tubing.The device was not re-sterilized prior to this incident.A new device was used.No patient harmed reported.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 06/23/2023.An investigation was conducted on 07/05/2023.Only the btt, syringe, and endoscope tip were returned.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the btt.No visual defects were observed on the btt.A mechanical evaluation was conducted.The btt was able to be inflated.No visual or physical defects were observed on the silicone of the btt.A 5cc syringe filled with saline was attached to the co2 line on the btt.The syringe was depressed to spray the saline.There was no backflow observed in the co2 line.Based on the returned condition of the device and investigation results, the reported failure "infusion or flow problem" was not confirmed.The lot#: 3000250496 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.
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: 17248506
• Report Number: 2242352-2023-00531
• Device Sequence Number: 4834208
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2023

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: 06/20/2024
• Device Model Number: VH-3200
• Device Catalogue Number: VH-3200
• Device Lot Number: 3000250496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: UNKNOWN.
• Patient Sex: Male
• Patient Weight: 102 KG