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

Catalog Number 0642-393-01

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the event report contacting the user facility to request an incident report, service records, and a description of the event.Despite reasonable attempts to obtain investigation information from the user facility, lumenis is unable to confirm the validity of the reported event.Lumenis requested service reports from the distributor regarding the subject device, however; none were provided as they said those records would need to come from the user facility itself.It could not be determined if the subject device operated to manufacturer's specifications.A review of the subject device history records (dhr) determined that the subject device was manufactured and tested according to manufacture specifications.Should lumenis receive any new information, the safety complaint will be re-opened and investigated accordingly.Device not returned for investigation.

Event Description

Rupture of the laser probe (slimline ez200) at about 5 cm from its distal end.The breaking of the fiber, being endo-urological treatment, occured inside the operating channel of the flexible ureteroscope resulting in damaging the tool.The episode has also resulted in a significant prolongation of operator's time for the recovery of the distal end of the telephone base migrated fiber within the calico-pielica cavity.

Manufacturer Narrative

***additional information*** the mdr for this event had initially been reported as a product problem (malfunction) only.Although the doctor was able to remove the broken fiber fragments from the patients kidney and no patient harm had been reported, lumenis has changed the reported event to an adverse event in addition to the initially reported product problem (malfunction) as medical intervention was required to preclude serious injury.Device not returned.

Manufacturer Narrative

Correction - june-10-2018.During a re-evaluation of lumenis' reportable malfunction list (b)(4) on june-06-2018 it was found that although this event was determined to be mdr reportable as a malfunction and adverse event; re-evaluation of this event had concluded that no injury had occurred.A historical product complaint review revealed that in more than two years since this reported event there have been no reports of injury having been associated with the same malfunction.Based on the information above lumenis is changing the record of this mdr to malfunction, and lumenis is removing this event from its reportable malfunction list.

• 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
• MDR Report Key: 6247123
• MDR Text Key: 64737262
• Report Number: 3004135191-2017-00002
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2018

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 Catalogue Number: 0642-393-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided; 06/06/2018
• Supplement Dates FDA Received: 05/23/2017; 06/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR