MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3000

Device Problems Self-Activation or Keying (1557); Smoking (1585); Failure to Shut Off (2939)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 hemopro was self-activating and would not shut off.Smoke was accumulating in the patient's leg and the tip of the cautery was glowing bright orange despite not being activated.The hospital removed the cautery and cannula from the patient's leg and dunked the tip into saline to cool it and avoid any fire potential.A replacement device was used to complete the procedure.There were no patient burns.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The hp1 device was returned to the factory for evaluation.Signs of clinical use and evidence of blood was observed.A visual inspection was conducted.Blood and charred tissue was observed on the heater wire.The heater wire was observed to be flexed away from the center of the hot jaw, but remained attached at the base and tip.No other visual defects were observed.An electrical evaluation was conducted.A pre-cautery test as was performed per the instruction for use (ifu) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 5 times while the cable connections were manipulated with no observed failure.The handle was opened to evaluate the internal components.No visible defects were observed to the toggle.The switch was examined under microscopy.No residue or contamination was seen on the switch.We were unable to observe any electrical issues or failure to energize for the complaint unit during our testing.Based on the results of the evaluation, the reported failure mode ¿self-activation or keying¿ was not confirmed, but was confirmed for analyzed failure "material twisted/bent; wire".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro was self-activating and would not shut off.Smoke was accumulating in the patient's leg and the tip of the cautery was glowing bright orange despite not being activated.The hospital removed the cautery and cannula from the patient's leg and dunked the tip into saline to cool it and avoid any fire potential.A replacement device was used to complete the procedure.There were no patient burns.The hospital did not report any patient effects.

• Brand Name: VASO VIEW HEMOPRO
• 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: 8207144
• MDR Text Key: 131901157
• Report Number: 2242352-2018-01388
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052274
• 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
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25142529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 85