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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2022
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 reported loss of suction with one patient 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, the energy check and the ablation check were performed successfully without issue.The logfile shows that the user performed one energy check and then performed ten treatments without further energy check on that day.The logfile shows ten successfully performed treatments.The reported treatment could be identified in the logfile.The surgeon has had difficulties to reach a valid suction two value.Meanwhile, he lost the valid value for suction one.The surgeon pressed the foot pedal during the vacuum process and stopped the vacuum process, the treatment was cancelled.The treatment of the patient's left eye (os) was aborted prior to procedure.The treatment was aborted by user.In summary, the patient interface lost suction before the laser fired.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.The system was working within specification.A root cause for the customers reported event could not be determined because according to logfile review the product met manufacturer¿s specifications; it is not likely that a product malfunction could have contributed to the reported event.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 one energy check and then performed ten treatments without further energy check on that day.The logfile shows ten successfully performed treatments.The reported treatment could be identified in the logfile.The surgeon has had difficulties to reach a valid suction two value.Meanwhile, he lost the valid value for suction one.The surgeon pressed the foot pedal during the vacuum process and stopped the vacuum process, the treatment was cancelled.The treatment of the patient's left eye was aborted prior to procedure.The treatment was aborted by user.In summary, the patient interface lost suction before the laser fired.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.The system was working within specification.Visual inspection of the applanation cone with a photomicroscope shows scratches and debris on the applanation surface.During functional inspection of the patient interface on the system shows a beam control check (bcc) error.This beam control check (bcc) error appears during the focus control routine of the applanation cone.A possible reason is that the applanation cone is dirty or damaged.The user must cancel the treatment and start again, using a new applanation cone.In this case the beam control check (bcc) error occurs due to the scratches and foreign material on the applanation surface.After carefully cleaning of the applanation cone the functional inspection of the patient interfaces shows no deviation during detection and focus control of the patient interface.The docking of the patient interface on a rubber test eye was performed without issue and a treatment would be possible.The docking process was retied several times and with two orientations of the suction ring but no lack of suction or instable suction could be reproduced.So, the reported problem cannot be reproduced during testing and no contributing factors can be identified.There is no problem with the patient interface.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications; it is not likely that a product malfunction could have contributed to the reported event.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: 16130149
• Report Number: 3003288808-2023-00015
• Device Sequence Number: 3253167
• Product Code: GEX
• UDI-Device Identifier: 00380659982989
• UDI-Public: 00380659982989
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 08/03/2023

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: 14R9YN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 03/24/2023; 07/14/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/12/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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 Sex: Unknown