MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 1000¿ REUSABLE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	SLIMLINE 1000¿ REUSABLE FIBER
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis contacted its foreign distributor in order to collect more information regarding the reported event; limited additional information was provided.According to the distributor "this was the only case observed at the hospital.It is 'an expected side effect due to user misuse already known as laser technology risk'.The user was reminded of recommendations for safe use by the local vigilance officer, and reminded of the 'warning of residual burning risk from a laser'." the distributor had concluded that "the problem follows a user error.Despite our reminders of good use procedures for fibers, they are routinely not inspected under a microscope before use.In this case, there is one of these two scenarios; reusable fibers are sent to sterilization without a protective cap and the fiber was not inspected before use, or the fiber was non-functioning following the previous treatment and was not inspected before use".A historical review of fiber complaints revealed no other events/incidents reported to lumenis with the same lot number.A review of subject device labeling (um-20006800) stated the following: "warning: when using a fiber optic delivery device, always inspect the fiber optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise damaged.A damaged fiber optic cable may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room" no device malfunction was alleged, nor does lumenis suspect device malfunction as being the cause or contributory to the event reported.Lumenis believes the most probable root cause to be "user error", failure to follow instructions and protocol of [?]safe use' by the facility's local vigilance officer.As a result of this event, the distributor has confirmed that the users have been reminded of "the recommendations for safe use" by the local vigilance officer.The distributor had further confirmed that the users have been reminded of "warnings of residual burning risk from the laser." considering the above 'reminders', no further action was determined necessary.As the severity of the burns was not confirmed, lumenis cannot rule out that a serious injury had occurred.In an abundance of caution, lumenis is reporting this as an adverse event.
Event or Problem Description
A foreign user facility reported that while changing a slimline 1000u fiber (lot# 60740116) on a lumenis pulse 120 laser, the fingers of a medical staff were burned.No report of patient injury or complications was received.

• Brand Name: SLIMLINE 1000¿ REUSABLE 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: 8580840
• Report Number: 3004135191-2019-00050
• Device Sequence Number: 1860392
• Product Code: GEX
• UDI-Device Identifier: 07290109140254
• UDI-Public: 07290109140254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2020
• Device Model Number: SLIMLINE 1000¿ REUSABLE FIBER
• Device Catalogue Number: 0627-497-01
• Device Lot Number: 60740116
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other