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 Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

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.Although the doctor was able to remove the broken fiber fragments from within the kidney 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.Device not returned to manufacturer.

Event Description

A user facility reported that during a laser lithotripsy procedure, a piece of a lumenis slimline 200¿ fiber broke off inside the patient's left kidney and the broken piece was retrieved successfully.No report of related injury or patient harm was received.

Manufacturer Narrative

Lumenis had inadvertently reported this mdr as an adverse event and product problem lumenis concluded that no patient harm or injury had occured.The physician removed the fiber fragments from the patient and completed the procedure with another slimline 200 fiber with no reported harm.Lumenis is withdrawing the adverse event report.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 still represents a reportable malfunction.Lumenis is correcting the event to be a product problem / malfunction only.

• 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: 6590087
• MDR Text Key: 75916419
• Report Number: 3004135191-2017-00071
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/16/2017

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 Expiration Date: 11/10/2020
• Device Model Number: SLIMLINE EZ 200¿
• Device Catalogue Number: 0642-369-01
• Device Lot Number: 58861215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: 10/19/2016
• Supplement Dates FDA Received: 07/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2015
• 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