MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065990941

Device Problem Suction Problem (2170)

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

Event Date 11/08/2019

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.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 health professional reported, suction two was lost after 60 percent of the raster pass during lasik flap creation of the right eye.The complication was explained to the patient and a retreatment is planned.Additional information requested.

Manufacturer Narrative

The root cause was faulty fittings.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Review of the logfiles for the day of treatment shows no errors or any relevant warnings.During start-up of the system the vacuum, the energy and the ablation tests were performed.The logfile shows multiple successfully performed treatments.The energy was stable during treatment day.The reported treatment could be identified in the logfile.During laser fired the error messages for suction and vacuum appeared and treatment was aborted.During the technical site visit, field service engineer (fse) replaced fittings with vacuum exchange set and verified voltages, ablation check and cut depth.Laser meets all specification as per service installation record.Fse confirmed reported event.After replacing the fittings with vacuum exchange set and checking boards, system meets specification.Most probable root cause is a faulty fitting for the vacuum system.Root cause could not be identified conclusively.Most probable root cause are faulty fittings.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 9397898
• MDR Text Key: 190000813
• Report Number: 3003288808-2019-01185
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR