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

Catalog Number 8065990794

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.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).

Event Description

A company representative reported on behalf of a surgeon, almost immediately after beginning refractive treatment on the left eye the laser gave an energy too high error.The surgeon tried to clear the message with the laser pedal.The procedure was aborted and tests were run on the laser.The treatment was then competed without further issues.Additional information requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received; the patient is doing well and without postoperative complications.

Manufacturer Narrative

Logfile review for the day of treatment shows the system passed successfully all initialization steps without any relevant deviation during the start-up in the morning.The user performed gas change, skipped the scanner test and performed the necessary energy, eye tracker and fluence test without any issue.The user performed treatments successfully the whole day.During treatment phase of reported treatment, the treatment stopped and shows an energy warning message.After several times of treatment running and treatment stopped due to warning message, the user aborted the treatment with 17% of the shots already fired.The user aborted the treatment and performed a gas change, an energy check, an eye tracker test and a fluence test successfully.After these tests the user restarted the treatment and finished it without any issue.During the on site visit, field service engineer (fse) replaced the emr board and cable for the sensor and returned device to specification per sir (service installation record).No deeper root cause analysis is possible.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: 9235899
• MDR Text Key: 170250970
• Report Number: 3003288808-2019-01046
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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?: Yes
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR