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

Model Number SLIMLINE 200¿ SIS FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the device lot number; therefore, the manufacture and expiration dates are unknown.A review of system risk files revealed the following three risks of fibers breaking inside body: risk #1 (1003791_g - risk # 8.1.1) 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 (1003791_g - risk # 8.2.1) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (1003791_g - risk # 8.3.1) 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 subject device is expected to be returned to the manufacturer for further investigation; if new information is received with which to determine a cause for the reported event, lumenis will file a follow-up mdr.

Event Description

A foreign user facility reported that during a tul procedure in which a lumenis slimline 200 reusable fiber was being utilized , 10mm of the fiber tip broke and remained inside the kidney.The fragment was removed using a basket forceps.No report of patient injury was received, and no report that the event caused or contributed to any change in the patient's condition.

• Brand Name: SLIMLINE 200 SIS 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: 9748993
• MDR Text Key: 212154476
• Report Number: 3004135191-2020-00004
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: 07290109140223
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2020

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 Model Number: SLIMLINE 200¿ SIS FIBER
• Device Catalogue Number: 0644-010-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: No
• 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