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 09/13/2018

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 physician reported vacuum was lost during a flap creation procedure.The procedure was completed.There was no harm to the patient.

Manufacturer Narrative

A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after treatment date.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 7930232
• MDR Text Key: 122652259
• Report Number: 3003288808-2018-01620
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1