MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS STAR; EXCIMER LASER

Model Number 0030-2450

Device Problems Charred (1086); Electrical /Electronic Property Problem (1198); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Udi #: (b)(4) the field service specialist (fss) visited site to evaluate the unit.Fss confirmed that the chair power cord, which is plugged into the laser was damaged /cut and that there was a black mark on the floor.Fss was unable to confirm whether or not the black mark was an indication of fire/smoke.Per fss, cord is routed below the chair and the laser and the cord somehow was caught between the floor and the docking plate of the laser.Fss replaced the damaged power cord, which resolved the issue.Fss verified the daily calibrations and the system was found to meet abbott medical optics specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported that the cord to the visx chair is spliced and the technicians saw a large spark.The customer stated that it appears to have caught on a loose screw on the main floor plate under the chair.Customer reported that the left eye was completed and when they were going to do the right eye, there was a sound and spark.There was a black residue, which seemed to be a sign of smoke under bed of the chair.Customer reported that the flap on the right eye had been lifted when the event occurred and there was a delay in surgery (approximately 1-1.5 hrs.).The doctor proceeded with the surgery and the right eye surgery was successfully completed during the same procedure.There was no patient injury during this case and no patient information was provided.

• Brand Name: STAR
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 5138121
• MDR Text Key: 27905463
• Report Number: 3006695864-2015-00683
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0030-2450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2001
• 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