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 07/19/2018

Event Type  malfunction  

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.(b)(4).

Event Description

A nurse reported a suction loss during lasik flap creation.The patient interface was changed and the surgery was completed without further issues.

Manufacturer Narrative

Sample was returned.Failure analysis shows the reported problem cannot be reproduced with the returned patient interface: visual inspection of the applanation cone of the patient interface shows liquid remains on the applanation surface and the cut track that indicates the patient interface were used to start a treatment.Functional testing of the patient interface with the laser system shows that the docking on a rubber test eye was performed without issue and a treatment would be possible.The docking process was retried several times and with two orientation of the suction ring but no lack of suction or instable suction could be reproduced.No deviation of docking or other issues can be detected.No problem was found with the patient interface.The reported problem cannot be confirmed.No problem with the returned patient interface can be identified.The root cause was changed to inconclusive ¿ no problem found.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The root cause could not be identified conclusively.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: 7915629
• MDR Text Key: 122155408
• Report Number: 3003288808-2018-01601
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 01/18/2019; 08/27/2019
• Supplement Dates FDA Received: 01/23/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1