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

Catalog Number C-VH-3000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/02/2018

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 device did not function at all.Power supply was replaced and this did not resolve the problem.Another hemopro device was opened and it functioned properly.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.Blood and charred tissue were observed on the heater wire.A microscopic inspection was conducted.The heater wire was observed to be twisted at the middle of the hot jaw, but remained attached at the base and tip of the hot jaw.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use with a reference cable and reference power supply vh-3010 at level 2.5 volts.The device failed the pre-cautery test; it did not produce visible steam and audible beeping sound during several activations.The pre-cautery test was repeated 10 times while the cable connections were manipulated.The result was the same.The handle was opened to evaluate the internal components.Microscopic inspection showed no residue or contamination on the switch.Based on the returned condition of the device and the results of the investigation, the reported failure mode "failure to deliver energy" was confirmed.The analyzed failure mode "bent wire" was also confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro device did not function at all.Power supply was replaced and this did not resolve the problem.Another hemopro device was opened and it functioned properly.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: 7536694
• MDR Text Key: 109118279
• Report Number: 2242352-2018-00489
• 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: 05/22/2018

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: 04/02/2019
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25138120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• 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