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 08/01/2019

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 device history record (dhr) for the device has been reviewed.The associated device was released based on company's acceptance criteria.(b)(4).

Event Description

A customer reported faulty suction.Additional information has been requested.

Manufacturer Narrative

The review of logfile for the day of treatment showed during start up, the vacuum check, the energy check and the ablation check were performed successfully without issue.The logfile showed successfully performed treatments.The energy was stable during the whole day.The treatment could not be identified in the logfile.The review of the complete day showed no relevant error or warning message due to suction.It could be possible that the user could not obtain suction prior to procedure so no error or warning message appears.No technical root cause was detectable.The system was working within specification.The root cause could not be determined conclusively.Technical root cause could not be determined as the system is performing within specifications and as intended.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: 8934756
• MDR Text Key: 155701725
• Report Number: 3003288808-2019-00850
• 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
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• 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?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1