MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 8065741076

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Type  malfunction  

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).

Event Description

A customer reported that the probe was out of order and it did not take correct measurements.Additional information has been requested.

Manufacturer Narrative

The company service representative examined the system and was able to replicate the reported event and identified the probe was the source of the issue.The company service representative requested a replacement probe.The pachymetry probe serial number (s/n) (b)(4) is manufactured by an outside supplier.Therefore, manufacturing information could not be obtained.The pachymetry probe was received and destroyed by technical services.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating that there was no patient impact.

• Brand Name: OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7997564
• MDR Text Key: 124955028
• Report Number: 2028159-2018-02235
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K844686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065741076
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OCUSCAN RXP OPHTHALMIC ULTRASOUND SYSTEM; PACHYMETRY PROBE STRAIGHT