MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200 DFL FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	SLIMLINE 200 DFL FIBER
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A search of the complaint database revealed that no similar complaints exist for the specified lot.A review of subject device risk files revealed the following risks of 'fiber breaking' and 'disconnection of fiber from laser': risk #1: ((b)(4)) triggered by "fiber standard usage causes fiber accelerated degradation" has the potential to lead to ineffective treatment and/or prolonged procedure.Risk #2: ((b)(4)) triggered by "disconnection of fiber from laser" has the potential to lead to ineffective treatment and/or prolonged procedure.In each of the above; the risks have been quantified and found to be negligibly small, and the risks have been characterized and documented as acceptable within full risk assessment.Furthermore, the risks both carry a minor potential 'hazard severity'.Lumenis laser user manuals reveal user instructions which alert the user that when there is 'no laser emission' or 'inadequate or no aiming beam' the user is instructed to replace the delivery system, and inspect & replace the debris shield if necessary.A clinical evaluation of similar fiber malfunctions had concluded that "fiber malfunction in the proximal end or connector will require replacing the fiber.Since it is a consumable product, it is the common practice that hospitals will maintain more than one fiber.Using a number of fibers in the same case is not an unusual scenario but rather part of the routine care where patient anatomy and treatment targets may change throughout the procedure and will require different fibers and approaches.Therefore, change of fiber, that did not cause serious injury such as delayed procedure/canceled procedure/use of alternative device etc, is not a reportable event in vast majority of the cases." in the reported case another fiber was exchanged and worked well, and no harm came to the patient or staff.Based on the above information, the same malfunction of intraoperative fiber malfunction would not likely lead to serious injury, thus the malfunction would not be reportable per medwatch decision tree.Lumenis is filing this report in response to the user facility's medwatch report mw5092013.
Event or Problem Description
On january 22, 2020 lumenis received a user submitted medwatch report mw5092013 in which the description of the event reads: "during a cystoscopy with laser lithotripsy and stent insertion procedure, a slimline 200 dfl laser fiber was opened and attached to the laser machine; when md attempted to use, it didn't work.Opened new fiber which worked without any problem.".

• Brand Name: SLIMLINE 200 DFL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9685083
• Report Number: 3004135191-2020-00001
• Device Sequence Number: 19751716
• Product Code: GEX
• UDI-Device Identifier: 07290109140261
• UDI-Public: 07290109140261
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2021
• Device Model Number: SLIMLINE 200 DFL FIBER
• Device Catalogue Number: AC-1001635
• Device Lot Number: 40490719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1