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

Model Number 0030-1479

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

The surgery center had requested a preventative maintenance(pm) on an excimer star laser system.A field service specialist(fss) visited the site to perform pm.During the pm, the field specialist indicated upon replacing the cooling lines and refilling the water bottle, the fss turned on the cooling pump and fans on the ac distribution board and it tripped the breaker due to the wires and connection at the cooling fans being wet.The fss made sure it was off and went to reseat the connector to the cooling fans and was shocked by the 110 voltage alternating current (vac) to the fans.

Manufacturer Narrative

The laser machine was examined and tested at the customer location by an abbott field service specialist (fss).The field service specialist (fss) performed a checklist and verified all modes of operations.In addition, a preventative maintenance was performed.The unit meets amo specifications.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

(b)(4).A record review was performed.The risks and mitigation's associated with electrical shock issues are identified in existing risk documents and no new risks were identified as part of this investigation.Labeling of directions for use and manual describes electrical safety precautions.Although, there are instructions/labeling for electrical safety precautions, the service manual does not include the electrical safety requirements in the presence of water.A service bulletin will be released to define electrical safety requirements when performing cooling system maintenance and definition of when to use main power circuit breaker one to turn off system and when the use of circuit breaker four is adequate.All pertinent information available to abbott medical optics has been submitted.

• 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: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 4909194
• MDR Text Key: 6833027
• Report Number: 3006695864-2015-00397
• 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 Facility,Company Representative,company representati
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0030-1479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2000
• 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