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

Catalog Number 8065990941

Device Problem Failure to Deliver Energy (1211)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

A technician reported that a doctor was only able to complete 35- 40% of a flap on a patient.The laser stopped while cutting the flap.Procedure was unable to be completed.The doctor was able to lift up the laser and remove the patient.The logfiles show a difference in the fundamental energy which stopped the laser from completing the flap.New information was received.Photo refractive keratectomy will most likely be preformed once the patient has healed.

Manufacturer Narrative

A review of the device history record was traceable to the reported serial number indicating that the product was processed and released for according to the product¿s acceptance criteria.During an onsite visit, the field service engineer (fse) analyzed the logfiles to determine customer reported issue.The fse found sensor drifted out of range.To fix this issue, the fse aligned the system and ran new energy routines and successfully completed system verification to specification.System alignment was needed due to energy sensor drifted out of range.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Logfiles have been analyzed by company technical support and concluded that the reported issue could be confirmed.The reason for the energy drift could not be verified conclusively.The root cause could not be determined 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: 11288906
• MDR Text Key: 231570998
• Report Number: 3003288808-2021-00065
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR