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

Model Number	VH-2004
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
Related to: (b)(4).The hospital reported that during endoscopic vein harvesting procedure, vasoview hemopro 2 read "occlusion" when it was plugged into co2 insufflation.Harvester tried new insufflation tubing with no success.With no insufflation, surgical assistant could not continue with laparoscopic approach after multiple attempts with two different harvesters.New tower with insufflation was attempted with no success either.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/15/2024.An investigation was conducted on 02/29/2024.A visual inspection was conducted.The harvesting device, cannula and 2 btts were returned for evaluation.There were no visual defects observed on either the harvesting device or the cannula.Signs of clinical use and evidence of blood was observed on the two btts that were returned.An email was sent to intake in regards to the 2nd btt returned.This complaint was opened as a result of the response from the rep.Photographs for the investigation are numbered as onetrack (b)(4) as that was the initially reported complaint.Both btts were evaluated.No visual defects were observed on the intact btts.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.The cannula was observed to be intact, no visual defects were observed.The insufflation tube and the water tube were observed to be intact.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson (id (b)(4) due: (b)(6) 2025).A reference endoscope was inserted into a reference vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch deflated slightly, the air was turned back on and the pouch re-inflated.The test was then repeated for the reported cannula.The reference endoscope was inserted into the complaint device and evaluated for air flow.The device passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The values displayed were within specified acceptable range which is 2195 sccm.Based on the returned condition of the devices as well as the evaluation results, the reported failure "improper flow or infusion" was not confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system a lot history record review was completed for 3000294082 the only lot shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last lot shipped to the account.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 EVH ACCSESSORY PACK
• 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: 18844816
• Report Number: 2242352-2024-00188
• Device Sequence Number: 7758194
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: 00607567700376
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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 Model Number: VH-2004
• Device Catalogue Number: VH-2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: INSUFFLATION TUBING, TOWER
• Patient Sex: Unknown