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

Model Number	VASOVIEWHEMPRO (US) VH-3000
Medical Device Problem Codes	Particulates (1451); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000.It was noticed that there was a hair under the "gasket" in the accessory tray.
Additional Manufacturer Narrative
Corrected sections: h6 device code changed.(b)(4).The device was not returned to maquet cardiac surgery for investigation, however a photograph was provided by the account.A photographic inspection was conducted on (b)(6) 2020.Signs of clinical use and no evidence of blood was observed.The plastic holder for the accessory components was observed to be opened.A brown strand of hair was observed under the gray seal in the package.No other visual defects were observed.Based on the photographic inspection, the reported failure "contamination / decontamination problem" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000.It was noticed that there was a hair under the "gasket" in the accessory tray.No patient involvement.

• Brand Name: VASOVIEWHEMPRO (US) 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: 10610919
• Report Number: 2242352-2020-00847
• Device Sequence Number: 2719243
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 02/23/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25150454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1