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 Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2017

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 incorrect biometric values.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Ad the company service representative examined the system and confirmed the reported event of incorrect measurement.The company service representative noted that the system was also freezing during startup.The company representative visited the site and was able to determine two contributing factors.The first was listed as the positioning of the probe (which was tangled) and in a bad position.This was making the probe susceptible to incorrect measurements.To alleviate this issue, the company representative repositioned the table in a different location, for better measurement allowance.The second issue was the fact that the outlet in the surgical suite (where the biometric equipment was plugged in to) was equipped with higher voltage ranges, noting a range above 240v ac.When the company representative moved the machine for the probe issue, the voltage range for the outlet plug fell into better parameters and both issues were resolved.The company service representative replaced the main printed circuit board (pcb) in order to resolve the issue.The system was then tested and met all product specifications.The system was manufactured on november 23, 2011.Based on qa assessment, the product met specifications at the time of release.Although the reported event was replicated and several contributing factors were identified, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• 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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7030087
• MDR Text Key: 92729493
• Report Number: 2028159-2017-04280
• 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,health
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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 Catalogue Number: 8065741076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other