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 03/05/2018

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 coagulation was not working properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood were observed.Traces of blood were evident on the tool handle and on the jaws.Charred tissues were also evident on the jaws.On microscopic inspection, the heater wire was observed to be bent and detached at the tip, but remained attached at the base.The silicone insulation on both cold and hot jaws were intact with no cracks nor peeling.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.During the pre-cautery test, it produced steam and audible beeping sound during five (5) 3-second activations.To evaluate the safety shut down system, a poly-fuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after a 10-second cooling period with no incident each time.The jaws were cleaned gently with saline and gauze pad as indicated in the instructions for use.An activation and transection capability test were performed over five (5) repetitions using "max life test method" (bacon test).The device activated and transected tissue six (6) times with no cautery failure observed.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.683 ohms which is within hemopro 2 final test specification.The device passed the temperature measurement test.The displayed temperature increased and turned ¿green¿ within the 2 second specified timeframe.The displayed temperature decreased once the toggle switch was released.Based on the returned condition of the device and the results of the investigation, the reported failure mode "failure to cut" was not confirmed.The analyzed failure mode "bent wire" was confirmed.Specific actions for the analyzed failure mode "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 coagulation was not working properly.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: 7431122
• MDR Text Key: 105664945
• Report Number: 2242352-2018-00345
• 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
• Report Date: 04/13/2018

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: 11/13/2019
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25135513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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