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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb bisector (ous), the bipolar ligating forceps were wider than normal and cannot hold the vessel tightly.They opened another unit of vv7 and finished the surgery.No harm to the patient.
Additional Manufacturer Narrative
Trackwise id # (b)(4).
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 06/16/2022.An investigation was conducted on 07/20/2022.Photographs were provided by the account.A photographic inspection was conducted.One bipolar electrode was observed to be bent.The other photograph observes a comparison of two devices, one that has an extended blade with intact electrodes and the other device has a bent electrode.The blade was observed to be partially extended in the photograph with the bent electrode.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.One of the bipolar blades was observed to be bent closest to the base of the electrode.The other bipolar blade was observed to be intact.A mechanical evaluation was conducted.The blue toggle was manipulated to extend and retract the blade.The blade was able to be retracted and extended with no physical or visual difficulties observed.Based on the returned condition of the device and the evaluation results, the reported failure "mechanical problem" was confirmed as well as for the analyzed failure "material twisted/ bent electrode".The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 25160012 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 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: 14685138
• Report Number: 2242352-2022-00514
• Device Sequence Number: 17527503
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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: 09/02/2023
• Device Model Number: VASOVIEW 7 XB BISECTOR (OUS)
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 25160012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 08/04/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/05/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown