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

Catalog Number 8065990941

Device Problems Suction Problem (2170); Failure to Align (2522)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

A customer reported vacuum exceeded limits and the flap was not completed in the right eye of a patient, during lasik surgery.

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 manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.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.During onsite visit, fse (field service engineer) replaced puf pcb board and performed system verification.System meets specifications as per sir (service installation record).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 issue.The energy was stabile during the whole day.The logfile shows zero successfully performed treatments.The reported treatment could be identified in the logfile.The treatment of the patient´s right eye was aborted by device after bed cut.Treatment was only ninety two percent complete.The laser showed the info message: warning info=vacuum exceeds limits - treatment is aborted.Repeat vacuum check buttons=.No relevant deviation between planed and performed energy is detectable for the reported treatment.The user operated surgery within the recommended energy settings.The thickness of the flap was thinner than the recommended flap thickness.Review of the log files for the treatment day does not show any other relevant warning or error messages.Without sample root cause could not be determined conclusively.Most probable root cause is a faulty puf pcb board.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: 15912079
• MDR Text Key: 307177251
• Report Number: 3003288808-2022-00331
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male