MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 550 REUSABLE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	SLIMLINE 550¿ REUSABLE FIBER
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the reporter to request additional information which had been provided.A search of the complaint database revealed that no similar complaints of "fiber breaks/fractures" exist for the specified lot.A review of system risk files revealed the following risks: risk #1 (1003791_l - risk # 8.1.1) triggered by "user damages fiber external surface during operation" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #2 (1003791_l: - risk # 8.2.1) triggered by "fiber is damaged during shipment" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #3 (1003791_l - risk # 8.3.1) triggered by "user error (e.G.Excess energy) causes mechanical damage to fiber" has the potential to lead to prolonged procedure, equipment damage, patient/user/staff injury.Risk #4 (1003791_l - risk # 2.6) triggered by fiber standard usage causes fiber accelerated degradation' that has the potential to lead to ineffective treatment and/or prolonged procedure.In each of the aforementioned; the risk has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.In the reported event, an alternate device was used to complete the operation with no reported injury or patient complications having been received.In an abundance of caution, lumenis is reporting this as an adverse event.This case is a possible aro however, there is no need to send a separate aro report to the fda, since it is being reported as an mdr.No corrective action or remedial actions were deemed necessary.The subject device is expected to be returned to the manufacturer for further investigation; upon receipt and completion of the failure analysis of the device, if there is any further relevant information from that review, or should additional relevant information become available, a follow-up mdr will be filed.
Event or Problem Description
A foreign user facility reported that during a pulmonary procedure in which a lumenis versapulse powersuite 80/100 laser system with a lumenis slimline 550¿ was being utilized, sparks/flame backfired leading to irreparable scope damage.The fiber and scope were removed from the patient and after a 15 minutes delay the procedure was completed with an alternate device.No report of patient complications was received, and no report was received alleging the device malfunction caused or contributed to any change in the patient's condition.

• Brand Name: SLIMLINE 550 REUSABLE FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 11654905
• Report Number: 3004135191-2021-00020
• Device Sequence Number: 11664257
• Product Code: GEX
• UDI-Device Identifier: 07290109140025
• UDI-Public: 07290109140025
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: SLIMLINE 550¿ REUSABLE FIBER
• Device Catalogue Number: 0624-149-55
• Device Lot Number: 57570520
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1