MAUDE Adverse Event Report: Lumenis Ltd.

Device Problem Device Operational Issue (2914)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Other  

• Manufacturer (Section G): Lumenis Ltd.; 6 hakidma street; po box 240; yokneam 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; IS 20692 ; 49599044
• MDR Report Key: 7953907
• Report Number: COR18001629-000
• Device Sequence Number: 1
• Product Code: EWG

Combination Product (Y/N)

• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/10/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/10/2018
• Is This A Product Problem Report?: No
• Device Operator: OTHER

Was Device Available For Evaluation?

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided

Is The Device Single Use?

• Is this a Reprocessed and Reused Single-Use Device?: No Answer Provided
• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 10/10/2018 Patient Sequence Number: 1