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 Code Available (3191)

Event Date 10/19/2019

Event Type  Injury  

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.Manufacturing record reviewed.The associated device was released based on company acceptance criteria.No abnormalities that could have contributed to this event were found.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a possible suction loss near the hinge during lasik flap creation of the right eye.This was not noticed until they attempted to lift the flap.When trying to lift the flap the surgeon noted difficulty breaking the tissue bonds near the hinge.An additional instrument was used to lift the flap and poked through it; this was not in the visual axis so the ablation was completed and patient is doing well postoperatively without complaints.Additional information is requested.

Manufacturer Narrative

A review of the treatment report shows the canal seems to be not visible even the setting for flap cut was within specification.The treatment shows an occurrence of vgb (vertical gas breakthrough) that could caused difficulty lifting of the flap.The user performed the surgery with recommend energy settings and no relevant deviation between planned and performed energy is detectable for the treatment.Review of the logfiles for the day of treatment shows during start up the vacuum check, the energy check and the ablation check were performed without issue.Also the image of the ablation check shows a valid and good test.All treatments were performed successfully on that day.The logfile review shows the suction time for almost all treatments were long except one.The reported treatment could be identified in the logfile.The vacuum suction time for the treatment waslonger than usual (about 45 sec.) a need of long suction time is most likely caused by the docking technique by the user as no vacuum problem was detectable according to the logfile.So the reported problem is most possible caused by bad docking or/ and patient¿s eye movement.No technical root cause was identified as the product was found to be within specifications.The most possible root cause is bad docking or/ and patient¿s eye movement.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: 9349860
• MDR Text Key: 167316665
• Report Number: 3003288808-2019-01148
• 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
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR