MAUDE Adverse Event Report: LUMENIS VERSA PULSE POWER SUITE DUAL 80/100W; INSTRUMENT, SURGICAL LASER

Device Problem Kinked (1339)

Patient Problem Burn(s) (1757)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

A kink was noted in holmium laser fiber.When technician activated laser and went to fix kink, he received a burn to his hand.

• Brand Name: VERSA PULSE POWER SUITE DUAL 80/100W
• Type of Device: INSTRUMENT, SURGICAL LASER
• Manufacturer (Section D): LUMENIS; 2033 gateway place; suite 200; san jose CA 95110
• MDR Report Key: 5789792
• MDR Text Key: 49426010
• Report Number: 5789792
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2016
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other