MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200¿ DFL DISPOSABLE SIS FIBER; LASER FIBER DELIVERY DEVICE

Model Number SLIMLINE 200¿ DFL DISPOSABLE SIS FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation of the reported event found that the reported malfunction of the slimline 200 dfl reusable fiber was similar to a device malfunction that was alleged to have caused or contributed to a potentially harmful situation.Although no injury was reported, this malfunction might lead to serious injury should it recur, and because the company is aware that a similar malfunction was alleged to have caused or continued to a serious injury (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.The complainant was unable to provide the subject device lot number.Therefore, the manufacture and expiration dates are unknown.The complainant indicated that the device had 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 dfl laser fiber during a ureteroscopy procedure, the tip of the fiber broke off in the patient.The tip was retrieved, and the procedure was completed with another slimline 200 dfl fiber.There were no patient complications reported as a result of this event, and the patient's status was reported to be fine.

• Brand Name: SLIMLINE 200¿ DFL DISPOSABLE SIS 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: 7315620
• MDR Text Key: 101843742
• Report Number: 3004135191-2018-00028
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/06/2018

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 Model Number: SLIMLINE 200¿ DFL DISPOSABLE SIS FIBER
• Device Catalogue Number: AC-1001635
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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