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

Catalog Number 8065990794

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A surgeon reported during refractive ablation the bed moves anywhere from.5 to 2 millimeters making the apex of the laser off in the z-axis.The issue appears to be weight related in patients over 150 pounds.The surgeon reports that he has to place his hand under the headrest during procedures although this causes his gloves to become unsterile.

Manufacturer Narrative

The device history record (dhr) for the device and bed has been reviewed.The associated device was released based on company acceptance criteria.During the onsite visit, the fse (field service engineer) replaced headrest, z motor, joystick and completed system verification as per sir (service installation record).Without sample no deeper root cause analysis is possible.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Control panel with joystick and headrest received.These parts are not related to complaint.Z- motor received.The reported issue is a known issue.Non conformance investigations were opened to address reported issues.The root cause was identified as patient bed mechanics.The z-motor was improved to prevent further issues.The root cause was identified as patient bed mechanics.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 10222565
• MDR Text Key: 197918968
• Report Number: 3003288808-2020-00368
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1