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

Catalog Number C-VH-4000

Device Problems Intermittent Continuity (1121); Intermittent Loss of Power (4016)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

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 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 using vasoview hemopro 2.While performing a radial artery harvest ,about half way through burning branches they started to have intermittent power when pulling back the toggle.They did not feel it was a time out feature creating the power loss.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.While performing a radial artery harvest, about half way through burning branches they started to have intermittent power when pulling back the toggle.They did not feel it was a time out feature creating the power loss.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).Specific actions for the analyzed failure mode are being maintained and documented under maquet's failure investigation report (fir) system.The device was returned to the factory for evaluation.Signs of clinical use was observed.There was evidence of blood detected.A visual inspection was conducted.Small amounts of tissue and charred blood were observed on the jaws, and heater wire.The heater wire was observed to be flexed away at the center of the hot jaw.The wire remained attached at the base and tip of the hot jaw.No other failures were observed.The device was evaluated for electrical function.A pre-cautery test was performed per the instruction for use with a reference cable, adapter and reference power supply at level 3.0.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.Based on the results of the evaluation, the reported failure ¿intermittent continuity¿ is not confirmed, however the analyzed failure "material twisted/bent; wire" is confirmed.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8472950
• MDR Text Key: 140623642
• Report Number: 2242352-2019-00370
• 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
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25143949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1