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

Catalog Number C-VH-4000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 would not completely close so cautery never activated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws would not completely close so cautery never activated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The hp2 device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.A visual inspection was conducted.Charred tissue and blood were observed on the jaws.Specks of blood were observed on the harvesting handle.A microscopic inspection determined that the heater wire was slightly bent at the center of the hot jaw.The wire remained in place at the tip and the base of the hot jaw.As per the instructions in instructions for use(ifu), the toggle was pushed to close the jaws to check the integrity of the jaws to align when closed.The jaws did not align with each other.A small gap remained between the two jaws.Due to the heater wire being slightly flexed, the jaws could not align when the toggle was pulled back to close the jaws.The bent heater wire acted as an obstruction for the jaws when they were tried to close.The dhr and shop floor paperwork were reviewed.No non-conformances were observed.The lot conformed to all the specifications and requirements.The vendor certifies that this device lot conforms to all applicable product specifications.Based on the return condition of the device and the evaluation results, the reported failure mode ¿mechanical issue; jaw; jaws did not match/up align¿ and analyzed failure "material twisted/bent; wire¿ were confirmed.Specific actions for the analyzed failure "material twisted/bent; wire¿are being maintained and documented under maquet's failure investigation report (fir) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws would not completely close so cautery never activated.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: 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: 7508601
• MDR Text Key: 108246212
• Report Number: 2242352-2018-00451
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

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: 02/10/2020
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25137131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 08/16/2018; 08/22/2018
• Supplement Dates FDA Received: 08/22/2018; 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2018
• 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