MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 100H; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number LUMENIS PULSE 100H

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

A lumenis service engineer visited the site six (6) days after the event.Upon arrival, the engineer found intermittent red screen errors, replaced a damaged hr optic on brick 1.After its optics was replaced the laser was restored to full power capability, and the system was returned to the facility having met specifications and ready for use.A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.The system was manufactured on 18-feb-2020 and installed at the customer's site on (b)(6) 2021.A review of subject device risk files ((b)(4)) revealed the risk of optical misalignment leading to inadequate treatment which may require re-operation/prolonged procedure as a recognized risk which has been quantified and found to be negligibly small.The risk likelihood has been characterized and documented as acceptable within a full risk assessment.A two-year historical review of similar complaints revealed that mirror failure during a procedure has not led to serious injury.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution lumenis is reporting this malfunction.Unrelated to the event, lumenis has initiated capa # 20001 to further investigate and address mirror issues of the holmium system.This complaint is being closed to capa # 20001, and therefore follow-up mdr is not required.Lumenis 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 Description

A user facility reported that during a lithotripsy procedure in which a lumenis pulse 100 was being utilized, the system system shuts down in the middle of a case.Unable to continue with the system an alternate device was brought in to complete the procedure.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 100H
• Type of Device: HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 13889934
• MDR Text Key: 291289245
• Report Number: 3004135191-2022-00010
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140520
• UDI-Public: 07290109140520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS PULSE 100H
• Device Catalogue Number: GA-1008944
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1