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

Model Number LUMENIS PULSE 30H

Device Problem Failure to Deliver Energy (1211)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

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 14-nov-2018 and installed at the customers site on (b)(6) 2016.A lumenis service engineer visited the site after the reported event and examined the device.Verified reported fault 49, replaced laser deck board and performed pyro calibration and after reconfirming its operation, the engineer returned the system to the facility in a working order.A review of historical product complaints from the past two years shows that the same malfunction of pyro error has not led to serious injury.A review of system risk files (1003215 rev h) revealed risk #2.1.2 "laser output measurement failure (e.G.Pyro detectors failure)" which have the potential to lead to ineffective treatment which may require re-operation -or- prolonged procedure.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.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 an alternate method as intervention to prevent permanent damage.In an abundance of caution, lumenis is reporting this malfunction.According to the gso expert, the pyro sensors are sensitive to movement and a calibration error is likely to happen during local transportation.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 Description

A user facility reported that during a cystoscopy, laser stone w/ basket and stent procedure in which a lumenis pulse 30h was being utilized, the system stopped and displayed error 49 "pyro main does not equal pyro safe".The user facility tried to troubleshoot but after ten (10) minutes delay the procedure was completed using a basket extraction.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
• Type of Device: HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG)
• 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: 13549393
• MDR Text Key: 290531986
• Report Number: 3004135191-2022-00006
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140698
• UDI-Public: 07290109140698
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS PULSE 30H
• Device Catalogue Number: GA-2000435
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2018
• 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