MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (OUS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEW 7 XB BISECTOR (OUS)
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure the vasoview 7 xb bisector (ous) was unable to cut and coag the patient¿s saphenous vein at cut setting of 30 and 40.The jaws are fully closed during insertion.There was no resistance.The procedure was completed with a new vasoview 7xb and a new karl storz autocon ii 200 esu.No delay on the procedural.No harm to patient.
Additional Manufacturer Narrative
Trackwise 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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure the vasoview 7 xb bisector (ous) was unable to cut and coag the patient¿s saphenous vein at cut setting of 30 and 40.It failed to cut the tissue on activation.The jaws are fully closed during insertion.There was no resistance.User suspected it could be a faulty esu too.The procedure was completed with a new vasoview 7xb and a new karl storz autocon ii 200 esu.No delay on the procedural.No harm to the patient.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 11/28/2022.An investigation was conducted on 12/01/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the bipolar blades or the cutter blade.A mechanical evaluation was conducted.The blue toggle was able to manipulated to retract and extend the cutter blade.An electrical evaluation was conducted.The device was evaluated for electrical function.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001599).The device passed the pre-cautery test with a reference generator (recommended setting at 18) and reference bipolar cord.An activation test was performed and the device activated repeatedly with no failure observed.The bipolar cord connection was manipulated during activation.The device remained active and no sparks was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time and no sparks were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was not confirmed.The lot # 25163305 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 or Problem Description
N/a.

• Brand Name: VASOVIEW 7 XB BISECTOR (OUS)
• Common Device Name: 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: 15933194
• Report Number: 2242352-2022-01003
• Device Sequence Number: 4467805
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: VASOVIEW 7 XB BISECTOR (OUS)
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 25163305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/13/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/30/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STORZ AUTOCON II 200 ESU.
• Patient Sex: Unknown