MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 1000¿ REUSABLE FIBER BSC; POWERED LASER SURGICAL INSTRUMENT

Model Number SLIMLINE 1000¿ REUSABLE FIBER BSC

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Since lumenis cannot rule out that the fiber tip had broken off in the patient's anatomy, 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 formentioned; 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.No injury occurred in this case and the patient was reported "to be fine".The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A user facility reported that "there were three (3) slimline 1000u fibers that were used on the same procedure.The tip of the fiber broke off on those three fibers.No patient complications reported.Patient was fine.The problem was noticed during procedure and it occurred inside of the patient." no report of injury was received, nor did the malfunction cause or contribute to any change in the patient's status.This report is for device #2 of 3.

• Brand Name: SLIMLINE 1000¿ REUSABLE FIBER BSC
• 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: 8195572
• MDR Text Key: 131398566
• Report Number: 3004135191-2018-00191
• 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,user facility
• Type of Report: Initial
• Report Date: 12/26/2018

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: No Information
• Device Expiration Date: 06/24/2022
• Device Model Number: SLIMLINE 1000¿ REUSABLE FIBER BSC
• Device Catalogue Number: 0641-047-01
• Device Lot Number: 88870717
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1