MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200¿ REUSABLE FIBER; LASER FIBER DELIVERY DEVICE

Model Number SLIMLINE 200¿ REUSABLE FIBER

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

No report of patient injury was received, and the event did not cause or contribute to any change in the patient's condition.A historical review of fiber complaints revealed no other events/incidents reported to lumenis with the same lot number.A two year historical review of similar complaints revealed no events involving lumenis fibers and patients having been injured due to fiber fragmentation in the patient's anatomy.To date lumenis is unaware of such events ever having been reported.A review of subject device risk management files ((b)(4)) revealed that fiber breaks inside the body is a recognized risk which has been quantified and found to be negligibly small.The risk has been characterized and documented as acceptable within a full risk assessment.While the information received does not confirm that a serious injury had occurred, it is uncertain if the event would likely cause or contribute to a serious injury if the malfunction were to recur, therefore lumenis is reporting this malfunction in an abundance of caution.The subject device is expected to be returned to manufacturer for further investigation; if new information is received with which to determine a cause for reported event, lumenis will file a follow-up mdr.

Event Description

A user facility reported that during a procedure in which a lumenis slimline 200 fiber was being utilized via ureterostomy, the fiber broke in the ureter imbedded in the stone.The 3 (three) inch piece of fiber was retrieved and removed with no injury or harm to the patient or staff.

Manufacturer Narrative

Additional narrative 17-jan-2019.Investigation results: one slimline 200 reusable fiber was received for evaluation on 07-jan-2019.Visual examination revealed that the fiber was broken due to excessive bending or exceeding the fiber tensile strength during use and/or broken under power.The fiber is burned and broken.The jacket is blackened.Fiber was broken approx.8.7 feet from the rubber attached to the sma.The noted damages indicate the cause to likely be due to excessive bending or exceeding the fiber tensile strength during use & wear.

• Brand Name: SLIMLINE 200¿ REUSABLE FIBER
• Type of Device: LASER FIBER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8150254
• MDR Text Key: 130657272
• Report Number: 3004135191-2018-00176
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: SLIMLINE 200¿ REUSABLE FIBER
• Device Catalogue Number: 0641-020-01
• Device Lot Number: 84680517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1