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

Model Number VH-4000

Device Problems Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro 2 cautery "plates came apart during normal use".The procedure was completed successfully.

Manufacturer Narrative

Tw id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: h6--medical device ¿ problem code corrected from code "4580" to "2981." the device was returned to the factory for evaluation on 03/15/2024.An investigation was conducted on 03/19/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.The harvesting device was returned inside the cannula.The tip of the harvesting device was observed to be bent forward.Signs of clinical use and evidence of blood was observed.The c-ring was observed to be intact with no visual defects observed.A mechanical evaluation was conducted.The tip of the shaft was moved back into its normal position without any visual or physical difficulties observed.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.The heater wire was observed to be flexed and bent away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.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 (b)(4).The device successfully transected tissue four (4) times.No final testing was conducted due to the condition of the heater wire.Based on the returned condition of the device, the reported failure "material twisted/bent wire " was confirmed as well as the analyzed failure "material twisted/ bent shaft" were observed.The lot # 3000357260 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.

• 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: 18894654
• MDR Text Key: 337553668
• Report Number: 2242352-2024-00244
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 3000357260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IAB S/N (B)(6).