MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

Device Problems Improper or Incorrect Procedure or Method (2017); Application Program Problem (2880)

Patient Problem No Information (3190)

Event Date 12/12/2017

Event Type  Injury  

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 records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A surgeon reported two patients with same identifiers resulting in one patient being treated incorrectly resulting in "different outcomes".The surgeon reports the iris registration is not working properly and the system did not inform him causing him to treat the wrong patient.Additional information has been requested.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.The system history shows that the laser was verified successfully prior to and after the date of treatment.The treatment report shows no abnormalities.The centering of the pupil was good throughout the surgery.The described iris registration is not an application of this device.A wrong interpretation by the user of the user manual and the applications of the system can be determined to have contributed to this event.According to the user manual the surgeon is responsible for selection of the right patient and the correct treatment data.A safety function (manual confirmation is required by the surgeon to continue treatment) is in place.No technical root cause can be identified.Based on the available information it can be determined that a user error lead to the reported event the manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• 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: nadia bailey ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8176152330
• MDR Report Key: 7179304
• MDR Text Key: 96874683
• Report Number: 3003288808-2018-00073
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: AJ
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Other Device ID Number: 00380659907944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 25 YR