MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC; OPTIVIEW DAB

Model Number 06396500001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Cancer (3262)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Sticking and leaking dispensers required repeat runs.The repeat runs exhausted the patient tissue sample and required a re-biopsy.This is the initial and final report.

Event Description

Failed runs due to sticking or leaky dispensers required repeating the runs and led to tissue sample of patient being exhausted.

• Type of Device: OPTIVIEW DAB
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer (Section G): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 5208777035
• MDR Report Key: 7658942
• MDR Text Key: 113049369
• Report Number: 2028492-2018-00011
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 06396500001
• Device Catalogue Number: 760-700
• Device Lot Number: E00712
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other