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

Catalog Number C-VH-3500

Device Problems Material Protrusion/Extrusion (2979); Device Fell (4014)

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

Event Date 10/22/2018

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 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 small pin that hold the jaws together was sticking up out of its normal position and the btt port valve, just fell right out.Hospital switched to distal insufflation when it fell out.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 hemopro small pin that hold the jaws together was sticking up out of its normal position and the btt port valve, just fell right out.Hospital switched to distal insufflation when it fell out.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.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be slightly flexed away from the hot jaw, but remained attached at the base and tip of the hot jaw.An engineering evaluation was conducted.The rivet pin was observed to be out of its normal position and bent forward.The root cause for the analyzed 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.There were no visual defects observed on the silicon insulation.The btt port was not returned for evaluation.A photograph inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt.The blue luer lock was observed to be detached from the valve.No other visual defects were observed.Based on the return condition of the device, and photographic inspection of the btt, the reported failure ¿material twisted/bent¿ and "break" are confirmed as well as confirmed for the analyzed failure "detachment of device or device component".

• 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: 8067026
• MDR Text Key: 127211271
• Report Number: 2242352-2018-01136
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 25141130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1