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 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro 2, exposed wire in jaw, noticed during set up.Not used on patient, fault was identified at beginning of set up.

Manufacturer Narrative

Internal complaint number: (b)(4).The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 25152647 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 01/13/2021.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be flexed and twisted away from the center of the hot jaw to the tip of the hot jaw with detachment at the tip.No other visual defects were observed.An investigation was conducted on 01/25/2021.A visual inspection was conducted.The device was returned inside the plastic protective shell.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be flexed and twisted from the center of the hot jaw to the tip of the hot jaw, with detachment at the tip.The clear silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.A strand of white material was observed on the cold jaw.The cannula was not returned for evaluation, therefore no mechanical evaluation was conducted.No other visual defects were observed.Based on the returned condition of the device, the reported failure "material twisted/ bent wire" was confirmed as well as for the analyzed failure "particulates".

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro 2, exposed wire in jaw, noticed during set up.Not used on patient, fault was identified at beginning of set up.

• 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: 11109555
• MDR Text Key: 225094927
• Report Number: 2242352-2021-00025
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 25152647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1