MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 EASYPACK PATIENT INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	1515
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported suction was lost into the treatment.Customer had problem with suction.New patient interface was completed the flap procedure with no issues.
Additional 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).
Additional Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.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 logfile shows that the user performed four energy checks between 07:32 am and 12:52 pm.The energy was stable during this period.According to the user performed 3 treatments after 14:52 pm without further energy check on that day.The logfile shows fifteen successfully performed treatments.The reported treatment could be identified in the logfile.The log file shows that the beam control check (bcc) was performed about thirteen minutes before the start of the treatment and not immediately before the treatment.The treatment of the patient's right eye was aborted due to the user released the laser pedal and pressed the vacuum pedal instead of the laser pedal, which caused the interruption of the treatment during bed cut.The reported issue is not caused by the system or the used patient interface.The info message displayed vacuum pumps stopped by foot pedal - treatment is aborted and indicated that the user shut down the vacuum pumps by pressing the vacuum pedal instead of the laser pedal.The user restarted the treatment on the same day with a new patient interface and finished the treatment without any problems.Review of the logfiles for the treatment day shows no relevant warning or error messages.No technical root cause could be identified.No sample evaluation is required even if the sample is returned as the root cause has been identified during logfile review.No technical root cause was identified as the product was found to be within specifications.The root cause is user handling.The treatment was stopped by pressing food pedal and could be finished successfully using another patient interface.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
• Common Device Name: 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: 16276156
• Report Number: 3003288808-2023-00042
• Device Sequence Number: 20494539
• Product Code: GEX
• UDI-Device Identifier: 00380659982989
• UDI-Public: 00380659982989
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K190392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1515
• Device Catalogue Number: 8065998299
• Device Lot Number: 14FN93
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female