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

Model Number	VH-4000
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 bottom jaw plastic piece on forceps seems to have melted.The jaws were intact prior to the procedure.A new device was used to complete the procedure.There was no delay.There were no components of the device (metal / silicone) that detached into the harvesting tunnel / inside the patient.There was no patient harm.
Additional Manufacturer Narrative
(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).Updated section - b4, g3, g6, h2, h3, h6, h11.Corrected section: b7 - other relevant history.The device was returned to the factory for evaluation on 04/16/2025.An investigation was conducted on 04/17/2025.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.There were no visual defects observed on the intact cannula handle or intact c-ring.There were no visual defects observed on the intact heater wire.The clear silicone insulation on the hot jaw was observed to be intact.The clear silicone insulation on the cold jaw was observed to be peeled back, exposing the cold metal jaw tip.There was no melting of the jaws observed on either the hot or cold jaw.The shaft of the device closest to the base of the jaws was observed to be slightly bent.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "melted-jaws" was not confirmed, however, the analyzed failures "peeled; delaminated; jaw" and "material twisted/ bent shaft" were observed.The lot # 3000456184 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 or the analyzed failures.

• Brand Name: VASOVIEW HEMOPRO 2
• 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: 21943191
• Report Number: 2242352-2025-0000505
• Device Sequence Number: 12934464
• Product Code: GEI
• UDI-Device Identifier: 00607567700307
• UDI-Public: (01)00607567700307(10)3000456184(17)270218
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/28/2025

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 Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000456184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown