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

Model Number VH-3500

Device Problem Peeled/Delaminated (1454)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  Injury  

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro vh-3500 a piece of the silicone jaw broke off in the patient during branch division.The piece was recovered by disconnecting the cord from cutter and grabbing with the jaws.No additional incisions were required.It was a normal branch division with the power supply set at 2.5.The case was completed by opening a new kit.There were no patient affects and the only delay was to change out the kit.

Manufacturer Narrative

Trackwise id#: (b)(4).Updated sections: b-4, g-4, g-7, h-2, h-3, h-6, h-10 the device was returned to the factory for evaluation on (b)(6) 2023.An investigation was conducted on (b)(6) 2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The heater wire was observed to be intact with no visual defects observed.The gray silicone insulation on the hot jaw was observed the to be intact with no visual defects observed.The gray silicone insulation on the cold jaw was observed to be peeled away from the base of the cold jaw to the closest part to the tip of the cold jaw.The detached silicone insulation was not returned for evaluation.Based on the returned condition of the device as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000355798 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 Description

N/a.

• Brand Name: VASOVIEW HEMOPRO
• 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: 18478311
• MDR Text Key: 332462875
• Report Number: 2242352-2024-00028
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000355798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORD AND POWER SUPPLY
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male