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

Model Number VASOVIEW HEMOPRO 2

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).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 preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 tip was broken.The heated element was detached.The patient was not in the room.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 tip was broken.The heated element was detached.The patient was not in the room.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25153623 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory on 10dec2020.An investigation was conducted on 22dec2020.A visual inspection was conducted.Signs of clinical use was observed, and no amount of blood was detected on the harvesting handle or jaws.The heater wire was observed to be flexed away from the hot jaw with detachment at the tip of the hot jaw, yet remained attached at the base.The clear silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.Based on the returned condition of the device, the reported failure "material twisted/ bent; wire" was 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: 11031652
• MDR Text Key: 222769021
• Report Number: 2242352-2020-01135
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• 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: 12/16/2020

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: 09/15/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25153623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1