MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065990941

Device Problems Suction Problem (2170); Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2021

Event Type  Injury  

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 Description

A physician reported that a suction break occurred during lasik treatment on the left eye.On the second attempt the bed was created but suction break occurred again during side cut.The physician used vanna scissors and completed side cut on the left eye.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicated 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 and treatment date.The review of logfile for the day of treatment shows all laser system functions were within specifications.During start-up of the system the vacuum, the energy check and the ablation tests were performed without any issue.The energy was stable during the whole day.The log file shows multiple patient successfully performed treatments.The reported treatment could be identified in the logfile.The reported left eye was treated twice.The beam control check for the left eye (os) was done about one minute before laser fired instead of immediately before firing in both treatments.During the first treatment, the patient interface was docked twice on the left eye (os) because the surgeon interrupted the suction process after reaching valid suction values (suction1 and suction 2) by pressing the foot pedal; laser was not fired yet.The vacuum process was repeated and successfully completed.The first treatment was aborted during bed cut from surgeon by pressing the foot pedal, and logfiles show the following info message: 'vacuum pumps stopped by foot pedal - treatment was aborted.Hence, the first treatment was aborted by the surgeon and not by the device.The first treatment was cancelled and was repeated afterwards.For the second treatment, the surgeon set the energy setting of canal cut to 0.10 j.During second treatment surgeon stopped the treatment once during bed cut by pressing foot pedal, proceeded with the treatment and completed it successfully.No relevant deviation between planned and performed energy was detectable.The thickness of the flap was thinner than the recommended flap thickness.No technical root cause could be identified.No technical root cause could be determined for the reported event.With current information a device malfunction could be excluded.According to available information the suction break and the incomplete flap was caused by user technique (docking and general handling).The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: 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: 12862812
• MDR Text Key: 281159637
• Report Number: 3003288808-2021-00471
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: 00380659909412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WAVELIGHT EX500 EXCIMER LASER; WAVELIGHT EX500 EXCIMER LASER
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Female