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

Catalog Number C-VH-4000

Device Problems Melted (1385); Device Operates Differently Than Expected (2913)

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

Event Date 02/18/2018

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 was not cauterizing as expected.The silicon on the jaws was observed to be melted off and the wire on the tip of the jaw was lifted off from the jaws.No piece of the hemopro jaws became separated and there was nothing left in the patients leg.A replacement was used to complete the case.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 and evidence of blood were observed.Traces of blood and charred tissues were observed on the jaws.Microscopic inspection showed the heater wire to be flexed away but remained attached at the tip and at the base of the jaw.The silicone insulation appeared 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.An activation and transection capability test was performed over five (5) repetitions using max life test method /bacon test.The jaws were cleaned per the ifu and the pre-cautery test repeated.The device activated and transected tissue six (6) times with no cautery failure observed.No smoke and/or steam which could be considered excessive were observed.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.665 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 modes "failure to cut" and "melted" were not confirmed.The reported failure mode "bent wire" was confirmed.Specific actions for the reported failure mode "bent wire" are being maintained and documented under maquet¿s failure investigation report (fir) system.

Manufacturer Narrative

(b)(4).

• 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: 7367734
• MDR Text Key: 103539164
• Report Number: 2242352-2018-00264
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2018

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: 11/06/2019
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25135379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 05/21/2018
• Supplement Dates FDA Received: 04/03/2018; 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 118