MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 30H; HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG)

Model Number	LUMENIS PULSE 30H
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the medwatch report, lumenis is not the manufacturer of the fibers that were reportedly, "laser fiber on the outside of the patient is lighting up." the manufacturer of the fiber has been made aware of the fiber issue.A lumenis service engineer visited the site three (3) days after the reported event, and was not able to duplicate the alleged failure.Upon inspection and full optic evaluation, the engineer found that the system meets lumenis specification, and is ready for use.Based on the information above there is no evidence that a lumenis product had malfunctioned in this event.In an abundance of caution, lumenis is reporting this malfunction in response to the user facility's medwatch report 2300720000-2020-8010.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)), and per post marketing surveillance procedure (doc no.: (b)(4)).
Event or Problem Description
On 25-nov-2020, a lumenis received a user submitted medwatch report 2300720000-2020-8010 in which the description of the event reads, "when they are using it (lumenis pulse 30h) the (non-lumenis) laser fiber on the outside of the patient is lighting up, tried 3 different laser fibers and the all did that." "the vendor (lumenis) came out and verified machine operation and believes the problem is the (non-lumenis) fiber that was used." 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: LUMENIS PULSE 30H
• Common Device Name: HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG)
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 10916201
• Report Number: 3004135191-2020-00090
• Device Sequence Number: 1335839
• Product Code: GEX
• UDI-Device Identifier: 07290109140698
• UDI-Public: 07290109140698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2020

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: LUMENIS PULSE 30H
• Device Catalogue Number: GA-2006098
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1