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 Codes	Electrical /Electronic Property Problem (1198); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
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 during an endoscopic vein harvesting procedure, vasoview 7 xb bisector stopped working and the plastic at the jaws was melted.Nothing fell into the leg.Patient was not injured.A new device was opened to complete the case.
Additional Manufacturer Narrative
Trackwise #(b)(4).The device was returned to the factory for evaluation on 08/15/2022.An investigation was conducted on 08/23/2022.A visual inspection was conducted.Signs of clinical use and evidence of charred material was observed on the cutting blade.There were no visual defects observed on the blade or the bipolar electrodes.A mechanical evaluation was conducted.The blue toggle was able to retract and extend the cutting blade with no physical or visual difficulties observed.The black shaft closest to the base of the jaws was observed to be melted.There were no other visual defects observed.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001599).The device passed the pre-cautery test with a reference generator (recommended setting at 18) and reference bipolar cord.An activation test was performed and the device did activate.The bipolar cord connection was manipulated during activation.The device did activate.The device did produced steam and the saline did ¿boil¿ on the test gauze each time.Based on the returned condition of the device, as well as the evaluation results, the reported failure "electrical/electronic property problem was not confirmed and the reported failure "melted;shaft" was confirmed.The certificate of conformance (c of c) was unable to be retrieved.The lot #3000234333 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.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 08/15/2022.An investigation was conducted on 08/23/2022.A visual inspection was conducted.Signs of clinical use and evidence of charred material was observed on the cutting blade.There were no visual defects observed on the blade or the bipolar electrodes.A mechanical evaluation was conducted.The blue toggle was able to retract and extend the cutting blade with no physical or visual difficulties observed.The black shaft closest to the base of the jaws was observed to be melted.There were no other visual defects observed.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001599).The device passed the pre-cautery test with a reference generator (recommended setting at 18) and reference bipolar cord.An activation test was performed and the device did activate.The bipolar cord connection was manipulated during activation.The device did activate.The device did produced steam and the saline did ¿boil¿ on the test gauze each time.Based on the returned condition of the device, as well as the evaluation results, the reported failure "electrical/electronic property problem was not confirmed and the reported failure "melted;shaft" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• 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: 15325321
• Report Number: 2242352-2022-00727
• Device Sequence Number: 17720714
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

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: 04/10/2024
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: C-VH-3200
• Device Lot Number: 3000234333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 01/26/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 12/22/2022; 01/26/2023
• 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
• Patient Sex: Prefer Not To Disclose