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	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise 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.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, hemopro power cord denmark was not burning/coagulating when function were activated.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 was not burning/coagulating when function were activated.The case was completed with a new getinge hemopro ii device.No harm to patient.
Additional Manufacturer Narrative
Trackwise #(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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." 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
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Analysis of production: (3331/2130/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period jan 2020 to dec 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device & testing of raw/starting materials: (10/213/67) the device was returned to the factory for evaluation on 01/31/2022.An investigation was conducted on 05/02/2022.A visual inspection was conducted.A photograph was provided by the account.A photographic inspection was conducted.The product and lot # were observed in the photograph.Signs of clinical use and slight evidence of blood was observed on the intact jaws.The clear silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.The heater wire was observed to be intact, with no visual defects observed.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.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 10-second cooling period with no incident each time.Based on the returned condition of the device, the reported failure "electrical /electronic property problem" was not confirmed.

• 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: 13170525
• Report Number: 2242352-2022-00013
• Device Sequence Number: 17239409
• Product Code: GEI
• UDI-Device Identifier: 00607567700864
• UDI-Public: 00607567700864
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/04/2022

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: 09/01/2023
• Device Model Number: VH-4000
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25159961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 05/04/2022; 05/04/2022; 05/04/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/01/2022; 02/21/2022; 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown