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 patient interface (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 (08:17 am) 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 treatment was aborted during beam control check.The logfile confirmed the error message displayed as error bcc (beam check control and focus control.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 has to cancel the treatment and start again, using a new patient interface.The user cancelled the treatment, restarted the treatment, and finished the treatment without any problems.Malfunction not confirmed.The treatment was aborted before the suction process started.Review of the logfiles for the treatment day shows no more relevant warning or error messages.The system was working within specification.Visual inspection of the applanation cone with a photomicroscope shows scratches, debris and an eye print, that indicates eye contact, on the applanation surface.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).
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 treatment was aborted during beam control check.The logfile confirmed the error message 'error bcc/focus control.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 has to cancel the treatment and start again, using a new patient interface.The user cancelled the treatment, restarted the treatment, and finished the treatment without any problems.Malfunction not confirmed.The treatment was aborted before the suction process started.Review of the logfiles for the treatment day shows no more relevant warning or error messages.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).

• 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: 16130116
• Report Number: 3003288808-2023-00016
• Device Sequence Number: 11572862
• 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