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

Catalog Number C-VH-3000

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Date 01/16/2019

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 preparation for an endoscopic vein harvesting procedure using vasoview hemopro.They noticed the tip of the cautery jaws appeared to be broken with exposed wires.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for investigation.Signs of clinical use were observed.There was no evidence of blood detected on the device.The silicone coating on the jaws were observed to be intact with no peeled or cracked areas.Microscopic observation revealed the heater wire to be slightly twisted at the tip and base of the jaw, while remaining attached in the center.There were no other defects detected.Based on the returned condition of the device, the reported failure "peeled jaw" is not confirmed, however, the analyzed failure "material twisted/bent; wire" is confirmed.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro.They noticed the tip of the cautery jaws appeared to be broken with exposed wires.No patient involvement.

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8318611
• MDR Text Key: 135742233
• Report Number: 2242352-2019-00159
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2019
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25142913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1