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

Model Number VH-4000

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, after ligating most of the branches on the vein, it was noticed that the black shaft on the harvesting tool had become bent and actually broke where it attaches to the white handle.No pieces of the device were lost.However, due to this defect, it was decided that the device was no longer safe to use and it was removed from the surgical field.A new hemopro 2 kit was opened and the case was finished with no other issues.The only surgical delay was the time needed to open a new hemopro 2 kit which was about 2 to 3 minutes.No injuries occurred due to the defect.

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.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/19/2024.An investigation was conducted on 02/22/2024.A visual inspection was conducted.Both the harvesting device as well as the cannula was retuned.There were no visual defects observed on the intact cannula or the intact c-ring.Signs of clinical use and evidence of blood was observed on the harvesting device handle.Heavy charr was observed on the intact heater wire.There were no visual defects observed on the both the cold and hot jaw clear insulation of the both the jaws.The black shaft closest to the handle of the harvesting device was observed to be split, exposing the inner contents of the shaft.A mechanical evaluation was conducted.The blue toggle was manipulated to open and close the jaws.The jaws of the device didn't open or close during the evaluation.Based on the condition of the device as well as the evaluation results, the reported failures "break; shaft" and "material twisted/bent shaft" were confirmed, as well as the analyzed failure "mechanical problem" was observed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000347797 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 failures.

• Brand Name: VASOVIEW HEMOPRO 2
• 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: 18865565
• MDR Text Key: 337447055
• Report Number: 2242352-2024-00214
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000347797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1