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

Model Number	VH-3200-W
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb bisector (ous) knob is slanted and render the saphenous vein branch cauterization inefficient.Per the video provided by the complainant, the blue toggle was not straight when advancing and retracting.It was still able to cut, however, the cutting was intermittent, on and off.New device was used to complete the procedure.There was a delay to change to a new set of vv7xb.No harm to patient.
Additional Manufacturer Narrative
Tw id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 12/11/2023.Videos were provided by the account.A video inspection was conducted on 12/13/2023.Signs of clincial use and evidence of blood was observed.There were no visual defects observed during the procedure with the cutting blade.The cutter blade was able to be retracted and extended in the video.Smoke was observed in the procedure while attempting a dissection.The blue toggle was observed to be not in its normal position on the harvesting device handle.No other visual defects were observed.A visual inspection was conducted on 12/13/2023.Signs of clinical use and evidence of blood was observed on both the harvesting device as well as the cannula.There were no visual defects observed on the intact cannula or in the intact c-ring.The blue toggle was observed to be not in its normal seated position due to clinical use.A mechanical evaluation was conducted.The blue toggle was manipulated to retract and extend the cutter blade.The cutter blade was able to be retracted and extended with no physical or visual difficulties observed.An electrical evaluation was conducted.The device was evaluated for electrical function.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 activated repeatedly with no failure observed.The bipolar cord connection was manipulated during activation.The device remained active and no sparks was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time and no sparks were observed.Based on the returned condition of the device as well as the evaluation results, the reported failures "electrical problem" and "mechanical problem" were not confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000310260 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, OUS
• 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: 18290579
• Report Number: 2242352-2023-00997
• Device Sequence Number: 15018867
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Model Number: VH-3200-W
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 3000310260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 110 KG