MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 120H; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number LUMENIS PULSE 120H

Device Problem Failure to Deliver Energy (1211)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

This complaint was originally reported to lumenis on the (b)(6) 2022 as not having occurred during a procedure (thus no patient involved).On 14-jun-2022 lumenis received a user facility submitted mhra ref: 2022/005/011/501/012.The new information has been added to the complaint.Complaint description "surgeon attempted to laser stone intra-operatively and laser machine has failed stating numerous errors.Error codes are 240, 268, 162, 224.This has resulted in having to abandon procedure and patient will need to return to theatre at later date.Patient did not come to any harm.Ureteric stent inserted to protect their ureter and kidney until new date for the procedure can be rebooked".

Manufacturer Narrative

This complaint was originally reported to lumenis on the (b)(6) 2022 as not having occurred during a procedure (thus no patient involved).On 14-jun-2022 lumenis received a user facility submitted mhra ref: 2022/005/011/501/012.Complaint description "surgeon attempted to laser stone intra-operatively and laser machine has failed stating numerous errors.Error codes are 240, 268, 162, 224.This has resulted in having to abandon procedure and patient will need to return to theatre at later date.Patient did not come to any harm.Ureteric stent inserted to protect their ureter and kidney until new date for the procedure can be rebooked" 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.Device was manufactured on 10-jan-2021 and installed at the customers site 02-dec-2021.A lumenis service engineer visited the site five (5) days after the reported event and confirmed the malfunction.The engineer replaced the switching module and after testing the system, it was returned to the facility having met manufacturer's specifications.A review of subject device product risk file (rd-1124690_ak) revealed risk # 2.4.2; "system failure" which has the potential to lead to prolonged procedure -or- ineffective treatment which may require re-operation.The risk likelihood has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within a full risk assessment.System bit and failures recovery mechanisms are designed to identify failures and attempt recovery.In case of failure the subject device lumenis p120 labeling (um_10012510_k) revealed under handling error messages and notifications, the following: " clear the message by pressing the acknowledge button and follow the suggested steps intended to clear the fault.Resume normal operation; if the same notification displays again, turn off the laser system for one minute and restart it.Resume normal operation.If the same notification displays again, record the error number and contact your local lumenis service representative.A two year historical review of similar complaints revealed that the same malfunction of switching module has not led to serious injury in the past.In this case, a stent was used to complete the procedure, the patient was awakened from general anesthesia and the case needed to be rescheduled, although there was no injury associated with this event, lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks, and in an abundance of caution, lumenis is reporting this event to the fda.The failed swm board is expected to be returned to lumenis for evaluation.Upon receipt and completion of the failure analysis of the complaint device, if the conclusion will be changed due to the analysis, lumenis will file a follow-up mdr.This case did not result in a death or serious deterioration in state of health, nor is there a serious public health threat.According to the meddev 2 12-1 section 5.1.3.5 expected and foreseeable side effects and based on the above, this is a known risk which is clearly documented in the product information (manufacturer labeling) and quantified in the technical documentation with appropriate risk assessment.Therefore, this case need not be reported by the manufacturer to the national competent authority, mhra.Attached below, the response to adverse incident report mhra ref-022/005/011/501/012.Lumenis will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.34-01-04-00) and per post marketing surveillance procedure (doc no.1005539).

• Brand Name: LUMENIS PULSE 120H
• 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: 14754091
• MDR Text Key: 303178326
• Report Number: 3004135191-2022-00016
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS PULSE 120H
• Device Catalogue Number: GA-0008700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• 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