MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Intermittent Continuity (1121)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hempro vh-3500 was having intermittent energy issues during use.Customer was able to use the device for the entire procedure but they said it just didn't feel right.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hempro vh-3500 was having intermittent energy issues during use.Customer was able to use the device for the entire procedure but they said it just didn't feel right.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: g4, g7, h2, h3, h6, h10.The device was returned to the factory on 21dec2020.An investigation was conducted on 30mar2021.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood was observed on the jaws.There were heavy amounts of charred tissue and blood observed on the heater wire of the harvesting device.Specks of blood were observed on the handle.There were no visual defects observed on the silicone insulation.An electrical testing was conducted.A pre-cautery test was performed per the instruction for use (ifu cv000006999 ) with a reference cable and reference power supply vh-3010 at level 2.5.The device did not pass the pre-cautery test; it didn't produce any visible steam.An engineering evaluation was conducted that identified the root cause of the "intermittent continuity".The handle of the hemopro tool complaint device was opened up to further investigate the device¿s switch (part# rm7001322).The hemopro tool complaint device switch was evaluated and it was observed to have an operating point (o.P.) that is lower than normal.Based on the returned condition of the device, the reported failure "intermittent continuity" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 25153739 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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hempro vh-3500 was having intermittent energy issues during use.Customer was able to use the device for the entire procedure but they said it just didn't feel right.The hospital did not report any patient effects.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10979945
• MDR Text Key: 220715379
• Report Number: 2242352-2020-01076
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 25153739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1