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

Model Number	VH-3500
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 silicon jaws were becoming separated from the jaw arm itself.No part completely separated, just looks "torn." it was noticed after the harvest was complete.The same device was used to complete the procedure.There was no procedural delay.Vein was fine and no patient issues.
Additional Manufacturer Narrative
Tw 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.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).The device was returned to the factory for evaluation on 07/25/2024.An investigation was conducted on 08/07/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed on both returned devices.There were no visual defects observed on the intact cannula or intact c-ring.The heater wire was observed to be intact with no visual defects observed.The gray silicone insulation on the hot jaw was observed to be intact.The gray silicone insulation on the cold jaw tip was observed to be peeled back from the middle of the cold jaw to the tip, exposing the metal cold jaw, but with no detachment of the cold jaw insulation.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000400713 history record review was completed.There were ncmrs, rework, or deviations documented for the reported lot number.[ncmr # (b)(4) two complaints ((b)(4)) were reported because there was no movement of the hot and cold jaws when thumb toggle on hp2 tool(c-vh-4000) was moved to the fully open and closed position].Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW HEMOPRO
• 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 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19949363
• Report Number: 2242352-2024-00910
• Device Sequence Number: 18383069
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: K153194
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 06/10/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000400713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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 Sex: Unknown