MAUDE Adverse Event Report: LUMENIS, LTD. VERSAPULSE POWERSUITE; LASER POWERED SURGICAL INSTRUMENT

Model Number VERSAPULSE POWERSUITE

Device Problem Kinked (1339)

Patient Problem Burn(s) (1757)

Event Date 06/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Lumenis investigated the reported event contacting the user facility to obtain relevant information regarding the reported adverse event which was provided.A review of historical installation records found a lumenis versapulse powersuite laser was installed at the user facility on 07/18/2005.A review of service records shows the device has had its annual preventative maintenance yearly.Laser malfunction is not the suspected root cause of the event reported.A review of subject device labeling stated the following: warning: when using a fiber optic delivery device, always inspect the fiber optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged.The fiber optic cable may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled.Do not clamp the cable with a hemostat or other instruments.If sterile tape is used, always remove the tape before lifting the cable.A damaged fiber optic cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.Caution: to prevent accidental laser discharge, always turn off the laser before connecting the delivery system.Warning to avoid possible damage to the optical system, use only qualified lumenis delivery systems.Using other than lumenis delivery systems may jeopardize safe operation or damage the laser and will void your lumenis warranty or service contract.Lumenis concluded that the laser technician failed to follow instructions in the subject device ifu and common medical practice for the safe use of laser medical equipment to be the root cause of the event reported.

Event Description

A user facility risk manager reported on medwatch (b)(4) that during a bronchoscopy procedure while using a lumenis versapulse powersuite laser, "a kink was noted in holmium laser fiber.When technician activated laser and went to fix kink", the technician received a burn to the hand.The initial reporter identified a sure flex 550 lithotripsy fiber, lot # s-llf550 as the subject device laser fiber delivery device, which is not a lumenis manufactured delivery device.It was further reported that the technician had healed.No information regarding a report of serious injury or medical intervention to preclude permanent impairment was received.Furthermore, the user facility reported that no harm to the patient had occurred.

• Brand Name: VERSAPULSE POWERSUITE
• Type of Device: LASER POWERED SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, yokneam 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, yokneam 20692 ; IS 20692
• Manufacturer Contact: brett godfrey ; 1870 south milestone drive; salt lake city, UT 84104 ; 8776566266
• MDR Report Key: 5984618
• MDR Text Key: 56349758
• Report Number: 3004135191-2016-00036
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSAPULSE POWERSUITE
• Device Catalogue Number: 0638-800-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1