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	04/08/2022
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A facility representative a patient with loss of suction with one interface.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
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 and the energy check were performed successfully without issue.The ablation test was performed successfully and without problems, but the ablation test image is blacked out because the microscope illumination was not turned on, therefore the ablation test image does not show any steps between the orientation lines.The logfile shows that the user performed two energy checks and then performed 10 treatments without further energy check on that day.The reported treatment could be identified in the logfile.Suction ring and patient interface was docked several times on patient¿s eye because the surgeon has had difficulties to reach a valid suction one and two value, the surgeon pressed the foot pedal and stopped the vacuum process, the treatment was cancelled.The treatment was aborted by user.In summary the patient interface lost suction before the laser fired.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 user restarted the treatment on the same day with a new patient interface and finished the treatment without any problems.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: 15042814
• Report Number: 3003288808-2022-00200
• Device Sequence Number: 6912374
• Product Code: GEX
• UDI-Device Identifier: 00380659982989
• UDI-Public: 00380659982989
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K190392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 141XYY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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
• Patient Sex: Unknown