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

Model Number VASOVIEWHEMPRO (US) VH-3000

Device Problems Fitting Problem (2183); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

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 was hard to advance back and forth within the harvesting cannula.Upon inspection they noticed that one side of the jaws was shorter than the other by around 2mm.The case was completed without incident.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 10/21/2019.An investigation was conducted on 12/09/2019.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed.The harvesting device was returned partially inside the cannula.Blood and charred tissue was observed on the heater wire.No visual defects were observed on the jaws.A reference hemopro device was used to measure the jaws, there were no visual defects observed.A mechanical evaluation was conducted.A reference endoscope was inserted into the cannula until the noticeable click was observed, with no difficulties observed.The test was repeated 3 (three) times with the same observations observed.Based on the returned condition of the device, the reported failures "fitting problem" and "defective component" was not confirmed.The dhr, shop floor paperwork 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 was hard to advance back and forth within the harvesting cannula.Upon inspection they noticed that one side of the jaws was shorter than the other by around 2mm.The case was completed without incident.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9302839
• MDR Text Key: 186314215
• Report Number: 2242352-2019-01243
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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: 12/09/2019

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: 08/28/2020
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25147796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/10/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1