MAUDE Adverse Event Report: LUMENIS, LTD SLIMLINE EZ 200; LASER FIBER DELIVERY DEVICE

Catalog Number 0642-421-01

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Lumenis has just become aware of this reported event and is currently investigating.A follow-up mdr will be submitted.

Event Description

"during fragmentation of stone in lower pole calyx of kidney, a 200um fiber broke leaving segment of laser fiber in kidney.Segment of fiber was 5-6 cm long and needed to be retrieved with a basket.New fiber used and same thing happened.All laser fiber safely retrieved, but incomplete treatment of stone fragmentation.Stent placed and patient sent for eswl.No harm to patient." fiber 1 - took ten minutes to retrieve the fragments.Fiber 2 - took twenty minutes to retrieve the fragments.This event is for fiber 1.

Manufacturer Narrative

A lumenis technical engineer examined the powersuite laser system one month after the event completing performance tests of all specifications and concluding the device operated to manufacturer's specifications.A review of the laser system and fiber's device history records (dhr) determined that the subject devices were manufactured and tested according to manufacture specifications.The fiber was returned to the manufacturer for testing and examination.A lumenis quality engineer examined the fiber and concluded that the "fiber was broken due to excessive bending or exceeding the fiber tensile strength during use.Visually, the fiber is broken and burned, appearing pinched or twisted which would cause the break".Most probable root cause for this event was determined to be a "use error", although the doctor was able to remove the broken fiber fragments from the patients kidney and no patient harm had been reported, lumenis is reporting this event as medical intervention was required to preclude serious injury.Corrected data: although the initial report of this mdr indicated that a product problem/malfunction contributed to the adverse event, it was concluded that device malfunction is not suspected as the cause or contributory to the event reported.

• Brand Name: SLIMLINE EZ 200
• Type of Device: LASER FIBER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• 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; yokneam, 20692 ; IS 20692 ; 49599044
• MDR Report Key: 6232054
• MDR Text Key: 64128172
• Report Number: 3004135191-2017-00003
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: 0642-421-01
• Device Lot Number: 61690216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention