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

Catalog Number 8065990713

Device Problem Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 healthcare professional reported the smell of gas following replacement of arf gas prior to a surgical procedure.The procedure was performed with no harm to the patient or staff.

Manufacturer Narrative

Device history records (dhr) for the device was reviewed.The associated device was released based on acceptance criteria.During an onsite visit the fse (field service engineer) replaced the gas gasket, in addition, the regulator connections and the gas pipe connections were strengthened along their entire length from the gas bottle to the entrance to the laser head.Fse performed leak tests and found no leak.A root cause could not be determined conclusively.Most possible root cause could be a faulty gas gasket.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
• MDR Report Key: 11072212
• MDR Text Key: 224404402
• Report Number: 3003288808-2020-00819
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1