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

Model Number VH-3010

Device Problems Intermittent Continuity (1121); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Tw id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the hemopro power supply was faulty.The power was on 3.There was intermittent cautery at first then nothing after a couple minutes.They swapped cords, etc.Second generator worked fine.The following day, the clinician states it was not the hemopro device that was the problem.The staff troubleshot by switching out the hemopro power supply and adapter the hemopro "cautery" worked normal and as intended.Minimal case delay for troubleshooting and had no effect on patient outcome.No patient injury.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the hemopro power supply s/n (b)(6) was faulty.The power was on 3.There was intermittent cautery at first then nothing after a couple minutes.They swapped cords, etc.Second generator worked fine.The following day, the clinician states it was not the hemopro device that was the problem.The staff troubleshot by switching out the hemopro power supply and adapter the hemopro "cautery" worked normal and as intended.Minimal case delay for troubleshooting and had no effect on patient outcome.No patient injury.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: d4--idu # corrected from "(b)(4)" to "(b)(4)".D4--catalogue/ version and model # corrected from "vh-4000" to "vh-3010".H6--medical device ¿ problem code corrected from "2587" to "1121".The device was not returned to maquet cardiac surgery for investigation; therefore, no evaluation could be performed.However, photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the power supply.It is not possible to confirm the reported complaint.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(4).The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: 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: 17674713
• MDR Text Key: 323074480
• Report Number: 2242352-2023-00725
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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
• Device Operator: Health Professional
• Device Model Number: VH-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMOPRO KIT.