MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE EZ SIS 365¿; POWERED LASER SURGICAL INSTRUMENT

Model Number SLIMLINE EZ SIS 365¿

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Lumenis received notice from the fda on 28-feb-2020 that this mdr had originally been submitted on 19-jul-2017 as a supplemental report with no initial record in the system.At the request of the fda this report is being resubmitted to correct that error.Additional manufacturer narrative: a review of the subject device history records (dhr) determined that the subject device was manufactured, tested, and found to have met all lumenis specifications prior to release of sale.Subject device was not returned to the manufacturer for further investigation, determination of cause could not be determined.An investigation of the reported event found that the reported malfunction of the slimline 365, 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 patient with no patient harm having been reported, this event still represents a reportable malfunction.Corrections: method code was initially selected in this initial mdr.As the code has since been made invalid, (device not returned) had been selected instead.Conclusion code was initially selected in this initial mdr.As the code has since been made invalid code (cause not established) had been selected instead.

Event Description

A user facility reported that while a physician was using a slimline ez sis 365, laser fiber through a flexible cystoscope to break up a stone in a pcnl procedure, the tip (approx 1.5 inches) broke off inside the patient.The tip was retrieved successfully and the case was completed with another slimline ez sis 365, laser fiber.Patient was reported to have been fine, no report of related injury was received.

• Brand Name: SLIMLINE EZ SIS 365¿
• 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; yokneam, 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 6724201
• MDR Text Key: 181738064
• Report Number: 3004135191-2017-00089
• 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: 07/19/2017

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 Expiration Date: 12/17/2021
• Device Model Number: SLIMLINE EZ SIS 365¿
• Device Catalogue Number: 0644-018-01
• Device Lot Number: 77180117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1