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

Model Number	VH-4001
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related to (b)(4).The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 (w/vasoshield) was not cutting and sealing.There was energy, but the jaws would not have enough heat, or cut/seal.They thought it may have timed out so they waited over 1 minute and tried again getting the same result.They switched out extension cable and pigtail and still got the same result.Since the last branch was so close to the wrist, they were able to clip the last branch manually with a clip and completed the case.After they were done with prepping the radial they tried to burn the device on a wet lap to test it again and it worked fine.Delay for the time it took to switch out the cords.No harm.
Additional 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Corrected sections: h1--type of reportable event corrected from "malfunction" to "serious injury" a lot history record review was completed for lot 3000415583 the only lot shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the only lot shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Neither a lot/serial number or a manufacture/expiration date was provided, therefore only a partial udi # could be provided.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 20352589
• Report Number: 2242352-2024-0001088
• Device Sequence Number: 7926649
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EXTENSION CABLE AND PIGTAIL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown