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

Model Number VH-4000

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/12/2024

Event Type  malfunction  

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 preparation for an endoscopic vessel harvesting procedure, vasoview hemopro 2 bisector tip was bent upon inspection.The device was not used on patient.No patient harm.

Event Description

The hospital reported that during preparation for an endoscopic vessel harvesting procedure, vasoview hemopro 2 bisector tip of jaw was bent upon inspection.The device was not used on patient.A new device was opened to complete the procedure.There was no delay or patient harm.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 04/01/2024.An investigation was conducted on 04/03/2024.Signs of clinical use and no evidence of blood was observed.The shaft tip of the harvesting device was observed to be bent slightly forward.The clear silicone insulation on both the cold and hot jaws was observed to be intact with no visual defects observed.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.No other visual defects were observed.No electrical testing was conducted due to the condition of the heater wire as well as the harvesting device shaft tip.Based on the condition of the condition of the device as well as the evaluation results, the reported failure "material twisted/ bent shaft" was confirmed as well as the analyzed failure "material twisted/bent wire" 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 # 3000363686 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: 19060134
• MDR Text Key: 339683907
• Report Number: 2242352-2024-00342
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: 3000363686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.