MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE; OPHTHALMIC EXCIMER LASER SYS

Model Number 8065990600

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

A customer reported that during treatment, a system message was displayed indicating that the secondary energy was too low.The event occurred during the second of five treatments.After that, the customer exchanged the gas and the following treatments were performed successfully.There was no pt impact.No further info is expected.

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.No further info is expected.(b)(4).

• Brand Name: ALLEGRETTO WAVE
• Type of Device: OPHTHALMIC EXCIMER LASER SYS
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer Contact: janet monroe ; 6201 s freeway; r3-48; fort worth, TX 76434 ; 8176152742
• MDR Report Key: 4355578
• MDR Text Key: 16176311
• Report Number: 3003288808-2014-01805
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065990600
• Device Catalogue Number: 8065990600
• Other Device ID Number: V2-1.02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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