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 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A lumenis service engineer visited the four days after the reported event.Upon arrival, the engineer performed troubleshooting and found servo mirror assembly optic that fell off and needs to be replaced.Will need to order and return.A review of the subject device history records (dhr) determined that the subject device was manufactured, tested, and found to have met all lumenis specifications prior to release of sale.The system was manufactured on 29-sep-2016 and installed at the customer site on (b)(6) 2016.A review of system risk files (b)(4); insufficient energy 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 full risk assessment.In this case, the patient was awakened from anesthesia, the procedure was cancelled, although there was no report of 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.According to the gso expert based on the age of the system, wear could have likely played a role in this failure.Therefore, no additional corrective or preventive action is determined necessary.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 ureter stone procedure in which a lumenis pulse 100 was being utilized, case saver mode error, appeared on the screen.Unable to complete the procedure, the patient was awakened from general anesthesia and the case needed to be rescheduled.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 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 10974401
• MDR Text Key: 242687593
• Report Number: 3004135191-2020-00092
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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