MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW VV6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2400
Medical Device Problem Codes	Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro one of the wire tips was bent.This prevented them from cutting and cauterizing properly.They pulled another one off the shelf and completed the case successfully.Patient was not harmed nor was there any time added to the case.
Additional 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.
Additional Manufacturer Narrative
Trackwise id#: (b)(4) , updated sections: b-4, g-3, g-6, h-2, h-3, h-6, h-11.The device was returned for evaluation on 07/22/2024.An investigation was conducted on 08/01/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.Heavy evidence of blood and tissue was observed on the device handle, including in the openings of the handle near the toggle and c-ring, as well as on the c-ring, blade, blunt tip, and cannula opening.The c-ring was able to be retracted and extended using the c-ring slider with no physical or visual difficulties.The bisector rod was also able to be retracted and extended within the cannula with no physical or visual difficulties; however the bisector blade was unable to be extended and retracted using the toggle due to the large amount of tissue present.A lot of force was used to extend the bisector due to the amount of blood observed.The bisector was observed to be bent.While attempting to extend the blade, a "pop" was heard.The rocker assembly was unable to be used to extend and retract the blade and did not function properly.The rocker assembly was unscrewed so the individual pieces could be examined.The pull rod ball was out of the socket of the rocker arm, providing no connection between the two components.Due to the lack of connection, the assembly came apart when the screws were removed with no physical force used.As demonstrated in the dhr, the device undergoes the final testing described in 90509699 part 6 (tool inspection) to ensure that the assembled device functions as expected before release from the factory.Based on the returned condition of the device and the evaluation results, the reported failures "material twisted/ bent" and "failure to cut" were confirmed, and the analyzed failure "mechanical problem" was observed.The lot # 3000389181 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 VV6 PRO
• 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 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19919452
• Report Number: 2242352-2024-00897
• Device Sequence Number: 18187162
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: 00607567700239
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K091733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2026
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000389181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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: ..
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 101 KG