MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200 DFL FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number SLIMLINE 200 DFL FIBER

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Lumenis cannot rule out that the fiber tip had broken off in the patient's anatomy, and in an abundance of caution lumenis is reporting this event.A search of the complaint database revealed that no other complaints exist for the specified lot.A review of system risk files revealed the following three risks of fibers breaking inside body: risk #1 (b)(4) triggered by "user damages fiber external surface during operation" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #2 (b)(4) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (b)(4) triggered by "user error (e.G.Excess energy) causes mechanical damage to fiber" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.In each of the aforementioned; the risk has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.No corrective action or remedial actions were deemed necessary.The procedure was completed normally with no harm caused to the patient as a result of this event.Device was discarded by the user and will not be returned for analysis; therefore a failure analysis of the complaint device could not be completed.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

On 06-feb-2019 lumenis received a user submitted medwatch report (ref: mw5082896) in which the event description reads: during cystoscopy with right-sided stent exchange, laser lithotripsy, and stone basket extraction - laser fiber of distal portion of the fiber became loose.Able to be taken out through penis without any identification of pieces left within the urethra.

• Brand Name: SLIMLINE 200 DFL FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• 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: marina shkedy ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8377937
• MDR Text Key: 141240793
• Report Number: 3004135191-2019-00024
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2021
• Device Model Number: SLIMLINE 200 DFL FIBER
• Device Lot Number: 14710818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1