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 09/26/2019

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.(b)(4).

Event Description

A customer reported, suction two was low during lasik flap creation of the right eye.Additional information received; the reporter states the application looked to be perfect.After the box with the suction error popped up it would not let them finish the flap although in past it would allow them to finish the flap.The flap was not completed and they switched to photo refractive keratectomy with out further complications.There are two related reports for this facility.This report addresses the patient's right eye, and another manufacturer report will be filed for the past incidents.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.The review of logfile for the day of treatment shows during start up the vacuum check, the energy check and the ablation check were performed successfully without issue.The logfile shows many successfully performed treatments.The energy was stable during the whole day.The reported treatment could be identified in the logfile.According to the logfile the treatment was aborted after the suction warning messages appeared.It could be possible, that the patient moved or rolled his eye and so the suction was lost.The user performed several vacuum checks without any error.No technical root cause of the system is detectable.The system was working within specification.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: 9221344
• MDR Text Key: 169067403
• Report Number: 3003288808-2019-01038
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR