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

Model Number SLIMLINE SIS 200¿ FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation of the reported event found that the reported malfunction of the slimline 200 fiber was similar to a device malfunction that was alleged to have caused or contributed to a potentially harmful situation.Because the company is aware that this malfunction was alleged to have caused or continued to a potentially harmful situation (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.The complainant indicated that the device has been disposed 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 while a physician was using a slimline 200 laser fiber during a bladder stone procedure, the tip of the fiber broke off in the patient.The tip was washed out of the bladder with cystoscope, and the procedure was completed with another slimline 200 fiber.There were no patient complications reported as a result of this event.

• Brand Name: SLIMLINE SIS 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; 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; IS 20692
• MDR Report Key: 7170838
• MDR Text Key: 97641653
• Report Number: 3004135191-2018-00009
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2018

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: Physician
• Device Expiration Date: 10/09/2021
• Device Model Number: SLIMLINE SIS 200¿ FIBER
• Device Catalogue Number: 0644-010-01
• Device Lot Number: 73991116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2017
• Initial Date FDA Received: 01/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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