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

Model Number 840-840

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

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

It was reported by a user facility, that the tip of a laser fiber broke off inside a female patient's ureter during a ureteroscopy procedure, and had to be removed using a zero tip basket.The procedure was completed with a different delivery device.No patient complications were reported.

Manufacturer Narrative

Lumenis has just become aware of this reported event and is currently investigating.A follow-up mdr will be submitted.It was reported by the distributor that "although the customer stated that the device was going to be returned, they never returned it." based on the information provided by the user facility & distributor a probable root cause cannot be determined at this time.Should additional information ever become available with which to determine root cause, the complaint record and mdr will be updated accordingly.

Event Description

It was reported by a user facility, that the tip of a laser fiber broke off inside a female patient's ureter during a ureteroscopy procedure, and had to be removed using a zero tip basket.The procedure was completed with a different delivery device.No patient complications were reported.

Manufacturer Narrative

As part of a remedial activity, lumenis conducted a retrospective review of all its slimline 200 fiber complaint files from january 2015 to may 2017.An investigation of the reported event found that although the fiber was not returned to manufacturer for product analysis, lumenis cannot rule out that product had malfunctioned.In an abundance of cation, lumenis is reporting this event as a product problem/malfunction, as well as adverse event as initially 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: 6265788
• MDR Text Key: 65357530
• Report Number: 3004135191-2017-00007
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2017

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 Model Number: 840-840
• Device Catalogue Number: M0068408400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/15/2017; 05/29/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention