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

Catalog Number 8065990713

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 01/18/2017

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 records (dhr) for the device were reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A surgeon reported the device stopped at the first second of treatment during laser ablation of the right eye.The surgeon tried to continue the case but was unable to and treatment was post poned.Upon additional follow up the treatment was attempted and completed five days following the initial attempt and the patient status is good post operatively.

Manufacturer Narrative

The system history shows that the laser was verified successfully prior the date of treatment.Logfile review could confirm the reported event.It is shown that an error message "wrong shutter state" was displayed which interrupted the treatment.The error message is caused by pushing the foot-switch (laser pedal) in hesitant or slow manner.The root cause can be determined as an inappropriate handling of the foot-switch (laser pedal).Pushing the foot-switch (laser pedal) in hesitant or slow manner will lead to this error message thus to interruption of the treatment.(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: rita lopez ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175514846
• MDR Report Key: 6329384
• MDR Text Key: 67609156
• Report Number: 3003288808-2017-00257
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Other Device ID Number: 00380659907135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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: 23 YR