MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4000

Device Problems Bent (1059); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 was extended into the operative tunnel and it was noted that the electrical wires were bent and dislodged from the insulation and the jaws.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.When hemopro tool was extended into the operative tunnel, it was noted that the electrical wires were bent and dislodged from the insulation and the jaws.

Manufacturer Narrative

The device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.Tissue and char buildup was observed on the jaws.A visual inspection determined that the heater wire was flexed away from the hot jaw with no detachment observed at the tip.The wire remained in place at the base of the jaws.Based on the returned condition of the device the reported complaint was confirmed for "bent wire.¿ since there was blood and tissue observed to the device it can be concluded that the most probable cause of the damage is during insertion/retraction of the hemopro through the cannula.The ifu states that the harvesting tool should be held approximately 6 inches from the tips and inserted carefully with the jaws closed and ensuring that the tips of the jaw are oriented upwards to prevent damage.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 was extended into the operative tunnel and it was noted that the electrical wires were bent and dislodged from the insulation and the jaws.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.When hemopro tool was extended into the operative tunnel, it was noted that the electrical wires were bent and dislodged from the insulation and the jaws.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5618150
• MDR Text Key: 44573828
• Report Number: 2242352-2016-00404
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

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: 10/13/2016
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25119721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR