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	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported a patient with suction was lost at the point of canal creation in the right eye during lasik surgery.There are multiple related reports for this facility.This report addresses a pi (b)(4), and additional manufacturer reports will be filed.
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 energy was stabile during the whole day.The logfile shows three successfully performed treatments.The reported treatment could be identified in the logfile.The treatment 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 cut.Therefore, the reported issue is not caused by the system or the used patient interface.The info message displayed as vacuum pumps stopped by foot pedal - treatment is aborted indicated that the user shut down the vacuum pumps by pressing the vacuum pedal instead of the laser pedal.No technical root cause could be identified.Review of the logfiles for the treatment day shows no relevant warning or error messages.The system was working within specification.The root cause is user handling.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 the wrong food pedal.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: 15078364
• Report Number: 3003288808-2022-00216
• Device Sequence Number: 17336735
• Product Code: GEX
• UDI-Device Identifier: 00380659982989
• UDI-Public: 00380659982989
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/30/2022

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: 144RKW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVELIGHT FS200 FEMTOSECOND LASER
• Patient Age: 27 YR
• Patient Sex: Male