MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2021

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 using vasoview hemopro vh-3500.When the product was opened, it was noted that the coating around the jaws of the bisector was falling off.Due to this defect, the device was immediately removed from the surgical field and a new hemopro device was opened.The defective device was not used on the patient and therefore there was no adverse outcomes due to this defect.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25152027 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 17feb2021 and investigated on 19feb2021.There were signs of clinical use & no evidence of blood observed on the jaws.A visual inspection device was conducted.The silicone insulation on the cold jaw was observed to be cracked and peeling without detachment.The heater wire was observed to be slightly flexed due to clinical use, but remained attached at the base and tip of the hot jaw.Based on the condition of the device as found, the reported failure mode was confirmed for ¿peeled; jaw".

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.When the product was opened, it was noted that the coating around the jaws of the bisector was falling off.Due to this defect, the device was immediately removed from the surgical field and a new hemopro device was opened.The defective device was not used on the patient and therefore there was no adverse outcomes due to this defect.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11378346
• MDR Text Key: 233496265
• Report Number: 2242352-2021-00176
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 25152027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1