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

Catalog Number 8065990941

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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.(b)(4).

Event Description

A customer reported difficulty maintaining suction one while trying to achieve suction two.Multiple attempts were made and the patient interface was exchanged multiple times.The surgeon elected to have to the patient come back to be treated but the patient was upset so the surgeon tried again to obtain suction.The surgeon finally able to obtain suction one and two and proceeded with treatment.The left eye side cut was incomplete.The patient will be retreated once the eye has healed.Additional information requested.

Manufacturer Narrative

A review of the logfile for the event day shows during start up the vacuum check, the energy check and the ablation check were performed without issue.Also the image of the ablation check shows a valid and good test.During the docking phase of the reported treatment the user took a long time to achieve stable suction one value, in the end he could perform the surgery successfully with a good and stable suction, there was no any error or warning message regarding suction problem during the treatment.Also all another four treatments were completed successfully without any problem.The reported problem is most possible caused by bad docking and patient¿s eye movement.The system shows no deviation which can contribute the reported problem from the technical side.No technical root cause could be identified.The most likely root cause is docking technique by the user or patient¿s eye movement and/or too much fluid on the eye.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
• MDR Report Key: 7965992
• MDR Text Key: 123941937
• Report Number: 3003288808-2018-01677
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR