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

Model Number	VASOVIEW 7 XB BISECTOR (US)
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector, they were taking vein on friday and towards the end of harvesting they were cutting some fascial tissue to open up the tunnel and the blade got stuck on one of the prongs and they were unable to get the knife in or out.There was no damage to the vein.No delay.No parts fell off.Device retrieved today.Used another device to complete case.No harm to patient.
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.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 07/14/2022.An investigation was conducted on 08/03/2022.Both the harvesting device and cannula were returned.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.The c-ring was observed to be intact with no visual or physical defects.A mechanical evaluation was conducted.The blue toggle was manipulated to attempt to extend and retract the cutter blade.The toggle would not move and the cutter blade would not retract or extend.The cutter blade was observed to stuck in between the bipolar blades at the base of the jaws.No other visual defects were observed.Based on the returned condition of the device and the results of the investigation, the reported failure "mechanical problem" was confirmed.The lot 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: VASOVIEW 7 XB BISECTOR (US)
• 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: 15071033
• Report Number: 2242352-2022-00628
• Device Sequence Number: 14780973
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 04/10/2004
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: 3000234333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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 Sex: Male