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 Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2015

Event Type  malfunction  

Event Description

A surgeon reported uncontrollable down movement of the bed during laser ablation and causing a delay in operation due to the need to stop and focus.Additional information has been requested.

Manufacturer Narrative

Additional information has been requested.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).

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.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 can be reproduced.The root cause was assessed to be related to the patient bed motor.(b)(4).

Manufacturer Narrative

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

Additional information received, 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: 4856476
• MDR Text Key: 5847867
• Report Number: 3003288808-2015-05703
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• 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: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2014
• 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