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

Model Number SLIMLINE EZ 200¿

Device Problem Material Fragmentation (1261)

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

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

As part of a remedial activity, lumenis conducted a retrospective review of all its slimline 200¿ fiber complaint files from january 2015 to may 2017.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.Three (3) reasonable attempts were made to obtain further information about the reported event from the user facility however none was received.Subject fiber had not been returned to manufacturer for product analysis despite the reasonable attempts, thus root cause could not be determined.In an abundance of caution lumenis is reporting this event as a product problem/malfunction.Although the doctor was able to remove the broken fiber fragments from within the patient and no patient harm had been reported, lumenis is also reporting this as an adverse event as medical intervention was required to preclude serious injury.

Event Description

A user facility reported that during a laser lithotripsy procedure, an inch from the tip of a lumenis slimline 200¿ fiber broke off inside the patient and "it took 45 minutes to fish the fiber out".No report of related injury was received.

• Brand Name: SLIMLINE EZ 200¿
• 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 ; 49599044
• MDR Report Key: 6587827
• MDR Text Key: 75856120
• Report Number: 3004135191-2017-00070
• 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: Other
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SLIMLINE EZ 200¿
• Device Catalogue Number: 0642-369-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2015
• 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
• Patient Outcome(s): Required Intervention