MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS S4-IR-CE; EXCIMER LASER

Model Number 0030-4966

Device Problems Fire (1245); Leak/Splash (1354); Failure to Power Up (1476); Smoking (1585)

Patient Problem Not Applicable (3189)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

Abbott technician was on site doing service and when he attempted to switch on the star laser so he could use the printer to print out his service report, smoke and flames were evident.This resulted to a small amount of damage to the inrush module within the ac (alternate current) box.There was no patient involvement.

Manufacturer Narrative

No patient involvement.Abbott tech specialist checked equipment and found that cooling water had leaked into the ac (alternate current) box causing the inrush thermistor and other components to fail.The ac box was replaced and tested.All measurements and lens calibrations were within abbott specifications.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Additional information: udi#: (b)(4).A review of the records related to this equipment shows the system met manufacturing release criteria.Equipment labeling provides potential adverse effects that can be caused by the surgical/treatment procedure being performed.Complaint data does not show any significant change over historical complaint limits.The operator manuals for the various equipment were reviewed and determined to include adequate warnings for medical complications.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: S4-IR-CE
• 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: 4842834
• MDR Text Key: 5938138
• Report Number: 3006695864-2015-00282
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: 0030-4966
• Device Catalogue Number: 0030-4966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2007
• 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