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

Catalog Number 8065990941

Device Problems Device Alarm System (1012); Suction Problem (2170); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

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

Event Description

A customer reported difficulty with vacuum two.Upon follow up, the site reported having vacuum two issues during flap creation with no patient harm.An error message appeared that suction pump two was too low while laser was firing.The laser stopped and flap was incomplete.Photo refractive keratectomy (prk) was done over the top.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.During technical onsite visit, the field service engineer (fse) could not duplicate the reported event.The review of logfile for the day of treatment showed during start up, the vacuum check, the energy check and the ablation check were performed successfully without issue.The energy was stable during the whole day.The reported treatments could be identified in the logfile.During laser firing, the an error message and a warning message appeared.Repeat vacuum check's occurred.The treatment was aborted.It could be possible that the patient moved or rolled his eye and the suction was lost.User repeated vacuum check and passed the vacuum check without issues.The treatment was not restarted at this date.Review of the logfiles for the treatment days prior to and after the corresponding treatment day showed no relevant warning or error messages.User operated within recommended settings.No technical root cause was detectable.The system was working within specification.No technical root cause could be identified.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: 9534112
• MDR Text Key: 191324264
• Report Number: 3003288808-2019-01284
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1