MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; CLAMP, VASCULAR

Model Number VASOVIEW HEMOPRO 2

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Trackwise id #(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.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws were not opening and closing properly and that the toggle switch on the handle was getting stuck.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(6).The device was returned to the factory for evaluation on 12/11/2019.An investigation was conducted on 01/29/2020.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred tissue was observed on the jaws.There were no visual defects observed on the heater wire or jaws.The shaft was observed to be snapped in the middle of the shaft, exposing the inner components of the shaft.A mechanical evaluation was conducted.The blue toggle switch was manipulated to open and close the jaws.The jaws would not open or close when the blue toggle was manipulated.An engineer evaluation was conducted.The engineer evaluation showed that based on the split shaft, the jaws would not open or close during manipulation of the blue toggle switch.Based on the returned condition of the device, the reported failure "mechanical issue" was confirmed as well as for the analyzed failure "material twisted/bent shaft".The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws were not opening and closing properly and that the toggle switch on the handle was getting stuck.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9509841
• MDR Text Key: 187055180
• Report Number: 2242352-2019-01410
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 25147896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR