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

Catalog Number 8065990941

Device Problem Suction Problem (2170)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

A non-health care professional reported suction break issue and also had weird problem with the system that caused a reboot and an aborted procedure in the patient left eye after laser ablation during lasik surgery.

Manufacturer Narrative

H.3., h.6.: 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).

Manufacturer Narrative

A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior and after the day of event.Most recent onsite visit from field service engineer (fse) was performed and signed service installation record (sir).System meets specification as per sir.During onsite visit the field service engineer (fse) performed a troubleshooting and service flash vacuum circuit check.The review of logfile for the day of treatment shows all laser system functions were within specifications.The vacuum check, the energy check and the ablation check were performed successfully without issues.The energy was stable during the whole day.The logfile shows thirteen successfully performed treatments.The reported treatment could be identified in the logfile.During the canal cut the warning message ¿suction pressure pump two too low¿ appeared once.After the bed cut the warning message ¿vacuum exceeds limits - treatment is aborted.Repeat vacuum check¿ appeared once.The treatment of the patient's left eye was aborted by the laser.No relevant deviation between planned and performed energy is detectable for bed and canal cut.The user operated not within the recommended energy settings.The thickness of the flap was thinner than the recommended flap thickness.The user restarted the treatment on the same day and finished the treatment without any problems.Review of the log files for the treatment day does not show any other relevant warning or error messages.The root cause could not be identified during logfile review.Root cause could not be determined conclusively.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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17745115
• MDR Text Key: 323396586
• Report Number: 3003288808-2023-00242
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: 00380659909412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Device Lot Number: 13UD7D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WAVELIGHT EX500 EXCIMER LASER
• Patient Age: 30 YR
• Patient Sex: Female