MAUDE Adverse Event Report: LUMENIS LTD. MOSES 200¿ D/F/L DISPOSABLE FIBER; LASER FIBER DELIVERY DEVICE

Model Number MOSES 200¿ D/F/L DISPOSABLE FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

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 complainant indicated that the devices have been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

A user facility reported that during a ureteroscopy procedure in which a lumenis moses 200¿ fiber was being utilized, the fiber tip snapped of about ten minutes into lasing the stone.The fiber tip was retrieved and removed, and a new moses 200¿ fiber was used.After another 15 minutes of lasing the tip of the second fiber also snapped off.Again, the fiber tip was retrieved and removed, and an unspecified 365¿ fiber was used to complete the case.No report of patient injury was received, and the event did not cause or contribute to any change in the patient's condition.This report is for device #1 of 2.

• Brand Name: MOSES 200¿ D/F/L DISPOSABLE FIBER
• 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
• MDR Report Key: 8263154
• MDR Text Key: 135455368
• Report Number: 3004135191-2019-00001
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: 07290109143170
• 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: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2019

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: 12/08/2020
• Device Model Number: MOSES 200¿ D/F/L DISPOSABLE FIBER
• Device Catalogue Number: AC-10030100
• Device Lot Number: 11430718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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