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

Model Number 1505

Device Problems Loose or Intermittent Connection (1371); Suction Problem (2170)

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

Event Date 04/05/2020

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 surgeon reported that while laser was firing, loose suction could be heard.Suction was lost and the procedure was stopped.The patient's procedure was completed on another day.

Manufacturer Narrative

A review of the device history record (dhr) was traceable to the reported serial number indicating that the product was processed and released according to the product¿s acceptance criteria.The review of logfile for the day of treatment showed the treatment was aborted due to the user released the laser pedal and pressed the vacuum pedal instead of the laser pedal which caused the interruption of the treatment during bed cut.The reported issue was not caused by the system or the used patient interface.Message indicated that the user shut down the vacuum pumps by pressing the vacuum pedal instead of the laser pedal.No technical root cause was identified.The root cause is user handling.The user released the laser pedal and pressed the vacuum pedal instead of the laser pedal which caused the interruption of the treatment during bed cut.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: 10332541
• MDR Text Key: 201843619
• Report Number: 3003288808-2020-00441
• 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
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1505
• Device Catalogue Number: 8065990898
• Device Lot Number: L04805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WAVELIGHT FS200 FEMTOSECOND, 8065990941, WAVELIGHT