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U.S. Department of Health and Human Services

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

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LUMENIS LTD. LUMENIS PULSE 30H; HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) Back to Search Results
Model Number LUMENIS PULSE 30H
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2020
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) 2019.A lumenis service engineer visited the site seven days (7) after the reported event and examined the device.The engineer found, after a few pulses, calibration error 49.Performed laser calibration and system tests including a pm.After reconfirming its operation, the engineer returned the system to the facility in working order.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.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.The laser was transported to the facility for rental.According to the gso expert, the pyro sensors are sensitive to movement and a calibration error is likely to happen in systems that are often transported between sites.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 ureteroscopy procedure in which a lumenis pulse 30h was being utilized, the system stopped and displayed error 49, "pyro main does not equal pyro safe." 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.
 
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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
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 Key10827330
MDR Text Key216380088
Report Number3004135191-2020-00080
Device Sequence Number1
Product Code GEX
UDI-Device Identifier07290109140698
UDI-Public07290109140698
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLUMENIS PULSE 30H
Device Catalogue NumberGA-2006098
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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