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

Model Number	1515
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2022
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 healthcare professional reported a patient with flap was not cut correctly into the cornea, but mainly into the patient interface.Patient impact was unknown initially.There are multiple related reports for this facility.This report addresses a patient interface (pi) ((b)(4)) and additional manufacturer reports will be filed.There are multiple related reports for this event.This report addresses the unknown patient's left eye and other manufacturer reports will be filed.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the event date.Most recent onsite visit from field service engineer (fse), fse field service engineer) performed and signed service installation record (sir).System meets specification as per sir.Logfile review for the day of treatment shows all laser system functions were within specifications.During start-up of the system the vacuum, the energy and the ablation tests were performed without any issue.The energy was stable during the whole day.Logfile shows six successfully performed treatments.The reported treatment could be identified in the logfile.Log file shows that the patient interface was docked several times on the left eye (os), as user aborted the suction process four times by pressing the foot pedal, after reaching valid values for suction one and suction two, so the suction process was repeated four times.The 5th attempt of the suction process was not aborted and the user continued the treatment.Treatment for left eye (os) was finished successfully without any issue.The entire treatment time was four minutes, from the start of the suction process to the end of the treatment.No relevant deviation between planned and performed energy is detectable for the reported treatment.The thickness of the flap was thinner than the recommended flap thickness.The user operated surgery within the recommended energy settings.No technical root cause could be identified.The received sample patient interface (pi) has been visually inspected and the reported event could be confirmed, it appears that the flap was partially shot on the pi (patient interface).The root cause cannot be identified conclusively.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: 15950389
• Report Number: 3003288808-2022-00336
• Device Sequence Number: 6371660
• Product Code: GEX
• UDI-Device Identifier: 00810462020023
• UDI-Public: 00000000000000
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 14HK6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 04/18/2023
• Date Device Manufactured: 04/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVELIGHT FS200 FEMTOSECOND LASER
• Patient Age: 36 YR
• Patient Sex: Female