MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990836

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2015

Event Type  malfunction  

Event Description

A surgeon reported to company representative that during a lasik procedure the patient bed was moving downward.Reporter indicated the surgeon had to stop and refocus until the uncontrollable bed movement stopped.Reporter relayed the procedure was completed and there was no patient harm; however the procedure time was delayed.

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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

During the onsite visit the fse (field service engineer) replaced the z-motor of the patient bed and performed adjustment.The failure analysis shows the problem cannot be reproduced.The motor worked fine during complete testing and with the maximum of the specified load.The root cause could not be determined conclusively as the failure analysis shows no problem with the sample.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.(b)(4).

Event Description

Upon additional follow up, reporter indicated the reported issue occured prior to the laser firing only, and not during the laser treatment.

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: eddie darton, md, jd ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 4853175
• MDR Text Key: 5808201
• Report Number: 3003288808-2015-05692
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990836
• Device Lot Number: ASKU
• Other Device ID Number: AQUA SP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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
• Patient Outcome(s): Other