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

Model Number	VH-4000
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tw (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
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 silicone from both jaws was found to be bare.She only found the silicone from one jaw so the silicone from the other could still be in the patient¿s leg.She said that she had been pulling the cautery out a few times to clean the jaws from char with a lap sponge.After approximately 3 times, she noticed it was bare of silicone coating.Also, she feels that the jaws weren¿t cutting which led to some bleeding (350ml in drain).The leg was wrapped as well.Finished the case using new kit.No patient harm.Pt is stable and improving.Leg drain was removed yesterday pod 2 after draining 80cc postop.No transfusions but h&h is down to 7.2/21.7 postop.Evh is looking fine.Silicone from one jaw was found between the legs on the drape.They just looked at the affected device and it still has the silicone coating on the second jaw so only one jaw had peeling of the silicone.All silicone is accounted for and none was left in the patient.
Additional Manufacturer Narrative
Trackwise# (b)(4).Corrected section: b1 - adverse event/product problem and b2 - outcome attributed to ae.The device was returned to the factory for evaluation on (b)(6) 2025.An investigation was conducted on (b)(6) 2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact heater wire.The clear silicone insulation on the hot jaw was observed to be intact.There was no silicone insulation on the entire cold jaw, exposing the entire length of the cold jaw.No other visual defects were observed.The detached cold jaw silicone insulation was not returned for evaluation.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) 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.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.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073.The device only was transect tissue four (4) times.No additional testing was conducted due to the peeled jaw.Based on the returned condition of the device as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was confirmed however, the reported failure "failure to cut" was not confirmed.The lot # 3000462060 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.
Event or Problem Description
N/a.

• 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: 21950114
• Report Number: 2242352-2025-0000517
• Device Sequence Number: 8720453
• Product Code: GEI
• UDI-Device Identifier: 00607567700307
• UDI-Public: (01)00607567700307(10)3000462060(17)270312
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000462060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown