MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER LUXOR Q-VUE; MICROSCOPE, OPERATING AND ACC., AC-POWERED, OPHTHALMIC

Model Number Q-VUE

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

A hospital nurse reported to a company field service engineer that the microscope assembly lost its main screw and fell down during surgery setup.The surgeon was able to catch the assembly part and there was no contact with or impact any pt.The microscope was also noted to have broken connectors.This issue resulted in the surgery starting later than planned.The field service engineer has gone to the facility and tightened the loose screws.The assembly was re-installed and all the screws were re-adjusted in the microscope.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

• Brand Name: LUXOR Q-VUE
• Type of Device: MICROSCOPE, OPERATING AND ACC., AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON -IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4570496
• MDR Text Key: 5553975
• Report Number: 2028159-2015-00283
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Q-VUE
• Device Catalogue Number: 8065752240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1