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

Catalog Number C-VH-3000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (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 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 tips were spread apart/misshapen.A replacement device was used to complete the procedure.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.A microscopic inspection was conducted.Blood was observed on the jaws.The heater wire was slightly flexed at the center of the jaw.The wire remained attached at both the tip and base of the jaw.No other visual defects were observed.Based on the return condition of the device, the reported complaint was confirmed for the reported failure mode "bent wire".

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro tips were spread apart/misshapen.A replacement device was used to complete the procedure.

• 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: 7401683
• MDR Text Key: 104809783
• Report Number: 2242352-2018-00303
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: 02/01/2019
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25136925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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