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

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

Although no injury was reported to be associated with this event, 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 serious injury (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.The device is expected to be returned to the manufacturer for product analysis.Once a cause for the reported event has been determined, lumenis will file a follow-up mdr.

Event Description

A user facility reported that after a physician had used a lumenis slimline 200 laser fiber to perform lithotripsy under flexible ureteroscope, and after the physician went into the ureter with a basket to remove the stone fragments, two (2) small fiber fragments were noticed having remained from the laser procedure.The stone and fiber fragments were safely removed with no report of patient complications as a result of this event.

• Brand Name: SLIMLINE 200¿ REUSABLE 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: 7103309
• MDR Text Key: 95736354
• Report Number: 3004135191-2017-00232
• 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: distributor,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2017

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: 01/01/2022
• Device Model Number: SLIMLINE 200¿ REUSABLE FIBER
• Device Catalogue Number: 0641-020-01
• Device Lot Number: 78060217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1