MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery stopped working while cauterizing a branch.It resumed after 15-20 seconds, but then stopped working again.It's likely the polyfuse feature was in effect, but it's not known.Another kit was opened to complete the procedure.There was no patient injury or delay in the procedure - aside from the few minutes to open another kit.
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
Tw # (b)(4).The device was returned to the factory for evaluation on 12/21/2023.An investigation was conducted on 01/02/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed on the device.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released with no excessive smoke observed.A tone was audible from the power supply upon activation.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after the 10-second cooling period with no incident each time.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (4) times.A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.688 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.Based on the returned condition of the device, the reported failure "electrical/electronic property problem" was not confirmed.The lot # 3000346932 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 HEMOPRO 2
• 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: 18376085
• Report Number: 2242352-2023-01058
• Device Sequence Number: 20737373
• Product Code: GEI
• UDI-Device Identifier: 00607567500006
• UDI-Public: 00607567500006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K101274
• 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): 01/18/2024

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 Expiration Date: 10/09/2025
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000346932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 110 KG