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

Catalog Number C-VH-3000

Device Problems Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(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.(b)(4).

Event Description

(b)(4).The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro tip fractured and fell into the evh tunnel and was unable to be located.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.(b)(4).Tip fractured during use and it fell into evh tunnel.Unable to locate the tip.Vh3000.Please send product replacement to (b)(4).

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Tissue and charred material was observed on the jaws.A visual inspection was conducted.The silicone insulation on the cold jaw was partially torn away from the tip.The boot remained attached at the base of the cold jaw.Based on the condition of the device as found, the reported complaint was confirmed for peeled jaw.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro tip fractured and fell into the evh tunnel and was unable to be located.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.Tip fractured during use and it fell into evh tunnel.Unable to locate the tip.(b)(4).Please send product replacement to (b)(6).

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5484163
• MDR Text Key: 40121351
• Report Number: 2242352-2016-00222
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2017
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25121874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR