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

Catalog Number C-VH-3500

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 09/28/2018

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 preparation for an endoscopic vein harvesting procedure, vasoview hemopro had a screw sticking out of the jaw area of the device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro had a screw sticking out of the jaw area of the device.A replacement device was used to complete the procedure.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.Although it was reported that during preparation there were signs of clinical use and slight evidence of blood was observed on the heater wire.The heater wire was observed to be slightly flexed at the center of the hot jaw, but remained attached at the base and tip of the hot jaw.The silicon insulation was observed to be intact.An engineering evaluation was conducted.The rivet pin was observed to be out of its normal position and bent forward.No other visual defects were observed.The root cause for the reported failure ¿detachment of device or device component" is undetermined because the event occurred during the handling of the device and the event history is unavailable for our review.However manufacturing was made aware of the malfunction and awareness training was conducted.A mechanical evaluation was conducted.The toggle switch was engaged, however the jaws would not open or close.Based on the return condition of the device, the reported failure "detachment of device or device component" was confirmed as well as confirmed for the analyzed failure "material twisted/ bent".

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7987028
• MDR Text Key: 124665996
• Report Number: 2242352-2018-01043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 25141151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1