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

Model Number VASOVIEW 6 PRO

Device Problem Mechanical Problem (1384)

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

Event Date 02/06/2024

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 an endoscopic vessel harvesting procedure, vasoview 6 pro knife of the bi-sector got hung up on the back side of the c-ring and was unable to dislodge while trying to engage a branch using the bi-sector and c-ring.A new device was opened to complete the procedure.There was a procedural delay to open the kit.There was no patient injury.

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.Signs of clinical use and evidence of blood was observed.The handle was observed to be intact with no visual defects observed.A mechanical evaluation was conducted.The blue toggle was manipulated to retract and extend the c-ring.There were no visual defects observed on the intact c-ring.The blue toggle was manipulated to retract and extend the cutter blade.There were no visual defects observed on the intact cutter blade.There were no visual defects observed on the bipolar jaws of the device.An electrical evaluation was conducted.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (b)(6).The device passed the pre-cautery test with a reference generator (recommended setting of 18) and reference bipolar cord.The bipolar cord connection was manipulated during activation.The device did produce steam and the saline did ¿boil¿ on the test gauze each time.Based on the returned condition of the device, as well as the evaluation results, the reported failure "mechanical problem" was not confirmed.The lot # 3000355823 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: EVH
• 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: 18818482
• MDR Text Key: 336965734
• Report Number: 2242352-2024-00168
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW 6 PRO
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000355823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 123 KG