MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (OUS) VH-3000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEWHEMPRO (OUS) VH-3000
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoviewhempro (ous) vh-3000, they found hair in the sterile box.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoviewhempro (ous) vh-3000, they found hair in the sterile box.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 25152296 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 not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed, however a photograph was provided by the account.A photographic inspection was conducted on 01/21/2021.A single brown/black hair was observed on the device.It is unclear if the top portion of the plastic protective shell covering is removed in the photograph.No other visual defects were observed.Based on the photographic inspection, the reported failure " contamination/decontamination problem" was confirmed.According to the manufacturing process instructions for evh packaging, the trays are inspected for any foreign particulates present and are vigorously vacuumed and sterilized using alcohol wipes before assembling devices inside the tray.Each device is inspected for the presence of any foreign particulates and wiped with alcohol wipes before being placed inside the tray.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• Brand Name: VASOVIEWHEMPRO (OUS) VH-3000
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11027808
• Report Number: 2242352-2020-01121
• Device Sequence Number: 16310500
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 06/29/2021
• Device Model Number: VASOVIEWHEMPRO (OUS) VH-3000
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 25152296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 76