MAUDE Adverse Event Report: LUMENIS, LTD FIBERLASE ROBOTIC DROP-IN GUIDE; CO2 LASER FIBER AND ROBOTIC DROP-IN GUIDE

Model Number FIBERLASE¿ ROBOTIC DROP-IN GUIDE

Device Problem Material Fragmentation (1261)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Lumenis is currently investigating the reported event directly with the user facility and the initial reporter.When additional information is provided to lumenis with which to determine a cause for reported event, lumenis will file a follow-up mdr.

Event Description

A surgeon reported that during a robotic fibroid case involving a lumenis acupulse and fiberlase robotic drop-in-guide (dig), a small piece of metal had suspectedly fallen out of a fiberlase robotic drop-in-guide (dig) and into the patient.The metal piece had successfully been recovered.

Manufacturer Narrative

Lumenis contacted the user facility to investigate the reported event.On march 14, 2017 the user facility provided a physician report of the event.On march 30, 2017 the fiber and dig ("drop in guide") used during the procedure were returned for product analysis, however the suspected debris which was removed during the procedure was not returned.Lumenis technical design and quality engineers examined the returned suspected devices by inserting the fiber into the dig, but the dig channel was blocked.By pushing the fiber strongly through the channel, the blockage was released and debris fell from the dig.The debris was collected and sent to a lab for analysis, and on april 4, 2017 the debris was identified as being a "composite multilayered structure", or fiber "leftovers" most likely remaining from activating the laser after a fiber had broken in the dig.A review of the subject dig devices history records (dhr lot# 64940516) determined that the subject devices were manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.A review of the subject fiber devices history record (dhr lot# 62850316) determined that the subject devices were manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.A sample of (b)(4) dig units from the same lot was evaluated.Upon visual inspection, all the units appeared intact and clean in their sterile pouches, with no evidence of debris.Each of the digs were tested by inserting a fiber into their channels.Two (2) units were found to have residual remains in the channels.The residue was collected and sent for lab analysis.On april 4, 2017, the residue was identified to be stainless steel particles up to 80¿ in size.Lumenis had initially classified this mdr as an adverse event, but in light of the new information of residual stainless steel particles possibly remaining after manufacturing, lumenis has changed this report type to a product problem/malfunction and adverse event.Although cause for the reported event is inconclusive since the suspected debris from the reported event was not returned for analysis, lumenis did discover that there is an ineffective cleaning process of the dig during manufacturing, which could result in residues of tiny stainless steel dust particles remaining in the dig channels.Lumenis has initiated a capa for corrective action of the cleaning process during manufacturing, and lumenis will continue to monitor all related incoming complaints.

Event Description

A surgeon reported that while using a fiberlase laser fiber with a robotic drop in guide (dig) to perform a davinci robotic myomectomy there was difficulty moving the fiber in and out of the dig.At one point, the surgeon observed a piece of metal on the pelvic sidewall, and removed the metal without incident.The metal appeared similar to the metal of the dig.

Manufacturer Narrative

Correction: ten of the thirty digs were evaluated in which a fiber was inserted horizontally into each dig (as described in the user manual), removed and re-inserted several more times, all over a white surface.An inspection of the white surface after each test indicated the digs were intact and clean, with no evidence of debris having fallen from the channels of the ten digs.Twenty of the thirty digs were evaluated by extreme conditions (not representative of actual clinical methods), in which a fiber was inserted vertically into each of the 20 digs, removed and re-inserted several more times, all over a white surface.Two (2) units were found to have left residual remains on the white surface.The remains were collected (the largest particle size was found to be 80u) and sent for lab analysis.The remains were identified as stainless steel (lot64940516).It was reported in mdr 3004135191-2017-00026 follow-up #1 that "lumenis did discover there is an ineffective cleaning process of the dig during manufacturing, which could result in residues of tiny stainless steel dust particles remaining in the dig channels." lumenis is correcting this statement since after further investigation through capa #17009, lumenis has determined that the cleaning process is adequate and being followed.The last follow up mdr for this event had been reported as a product problem (malfunction) and adverse event.Based on lumenis' re-evaluation of this event, and since there is no evidence that a lumenis product had malfunctioned in this case, lumenis is withdrawing the malfunction claim.Lumenis has changed the report type of this mdr report to be an adverse event only.Although the root cause cannot be determined, in an abundance of caution, and as part of lumenis' commitment to continuous improvement, lumenis has updated the dig manufacturing work instructions to include an additional inspection.Lumenis has decided to clarify the (b)(4) work instructions by adding additional inspections under magnification for every part of the dig.The cleaning section instructions were also clarified in order to assure that new employees to the process will easily understand the instructions and stay consistent with the current cleaning process.

Manufacturer Narrative

****correction**** 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 an adverse event; re-evaluation of this event had concluded that no injury had actually occurred.A historical product complaint review revealed this event to be a single event.Based on the information above lumenis is removing this event from its reportable malfunction list.Block h1 of this report has been corrected; making this reportable event type a malfunction.

• Brand Name: FIBERLASE ROBOTIC DROP-IN GUIDE
• Type of Device: CO2 LASER FIBER AND ROBOTIC DROP-IN GUIDE
• Manufacturer (Section D): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 6375375
• MDR Text Key: 68964014
• Report Number: 3004135191-2017-00026
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K100384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2018

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 Expiration Date: 04/24/2021
• Device Model Number: FIBERLASE¿ ROBOTIC DROP-IN GUIDE
• Device Catalogue Number: AC-0001300
• Device Lot Number: 64940516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided; 07/17/2017; 06/10/2018
• Supplement Dates FDA Received: 05/04/2017; 07/17/2017; 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 59