MAUDE Adverse Event Report: MAQUET CV VASOVIEW 6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-2400

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/13/2018

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 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 6 pro would not activate consistently when it was time to cauterize(intermittent continuity).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, vasoview 6 pro would not activate consistently when it was time to cauterize (intermittent continuity).A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The vasoview 6 pro device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.Specks of blood were observed on the proximal tip and harvesting handle.The c-ring was observed to be completely intact.The shaft was observed to be slightly bent at the proximal end.No other failures were observed.The device was evaluated for mechanical function.The bisector toggle could be moved freely but the bisector blade did not extended or retracted in conjunction with the bisector toggle movement.The handle of the cannula was opened to inspect the pull rod ball assembly.It was observed that the pull rod ball was dislocated from the socket on the rocker arm.The toggle was mechanically disengaged from the pull rod and failed to move the blade.The toggle failed to extend and retract the blade.Upon reseating the ball into the toggle switch socket, the blade moved forward and back ward but substantial resistance, possibly attributed to the slight bent on shaft at the front end.A electrical evaluation was conducted.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use.The device passed the pre-cautery test with a reference generator (recommended setting of 18) and reference bipolar cord.The bipolar cord connection was manipulated during activation.The device remained active and no intermittent continuity was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time.We were unable to reproduce the reported failure in our testing.Based on the results of the evaluation, the reported failure "intermittent continuity" was not confirmed but was confirmed the analyzed failures "material twisted/bent; shaft" and "mechanical issue".The dhr for the vasoview 6 pro subassembly and a certificate of conformance for the pullrod ball, vv6 pro were reviewed.The vendors certify that all the device lots manufactured and the product lot meets and conforms to all the applicable product specifications.

• Brand Name: VASOVIEW 6 PRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7488717
• MDR Text Key: 107573504
• Report Number: 2242352-2018-00426
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• 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: 05/04/2018

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: 01/29/2020
• Device Catalogue Number: C-VH-2400
• Device Lot Number: 25136797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Device Age: YR
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 93