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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
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 the vasoview 7 xb bisector jaw was twisted and partially secured.When inserting the tool into the harvesting cannula, the surgeon tried to use the tool to grasp the vein and discovered it was bent.No resistance was noted while inserting the harvesting tool into the cannula but while opening the jaw and trying to grasp the vein, the surgeon was unable to do so.There was a delay waiting to open a new device.No harm to the patient.
Additional Manufacturer Narrative
Trackwise id # (b)(4).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.The device was returned to the factory for evaluation on 09/09/2022.An investigation was conducted on 09/21/2022.A photographic was provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The cutter blade was observed to be extended and bent.No other visual defects were observed.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use and no evidence of blood was observed.There were no visual defects observed on the bipolar jaws.The cutter blade was retracted.A mechanical evaluation was conducted.The blue toggle was manipulated to extend and retract the cutter blade.The cutter blade would not extend.The cutter blade was observed to be bent in between the one bipolar jaw.There were no other visual defects observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/bent blade" was confirmed as well as for the analyzed failure "mechanical problem- blade not extending".The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The c of c is available for review as an attachment to the record.

• 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: 15327378
• Report Number: 2242352-2022-00738
• Device Sequence Number: 6362135
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/07/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male