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

Model Number SLIMLINE EZ 200¿ FIBER

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Despite reasonable follow up for additional information regarding the circumstances of the event; no additional information was provided.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.Subject device was returned to the manufacturer for visual inspection on 25-sep-2019.Initial findings revealed that the "tip of fiber is broken without burns or melting".Lumenis quality assurance had determined 'operational context' to be the root cause of the reported tip break; the complaint is associated with a product that meets the lumenis design & manufacture specification but due to anatomical/procedural factors encountered during the procedure performance was limited.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop ((b)(4)) and per post marketing surveillance procedure ((b)(4)).

Event Description

A user facility reported that during an ureteroscopy procedure in which a slimline ez 200 fiber was being utilized, the tip of the fiber broke off in the patient's ureter.The tip was removed with a basket and after replacing the fiber with a new one, the procedure was completed with no patient complications.The facility used another of the same device to complete the case with no patient complications.No report of injury was received.

• Brand Name: SLIMLINE EZ 200¿ 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: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9150441
• MDR Text Key: 207348673
• Report Number: 3004135191-2019-00113
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00729010914019
• UDI-Public: 0729010914019
• 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: Other
• Type of Report: Initial
• Report Date: 10/03/2019

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: 03/08/2014
• Device Model Number: SLIMLINE EZ 200¿ FIBER
• Device Catalogue Number: 0644-009-01
• Device Lot Number: 34360419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1