DORNIER MEDLITE 20WATT NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-27 for DORNIER MEDLITE 20WATT NA manufactured by Dornier Med Tech America.

Event Text Entries

[1102159] Laser malfunctioned and/or was not powerful enough to perform successful surgical procedure. I am writing this letter in reference to a laser issue in (2009). The case in question was scheduled for holmium laser lithotripsy of a bladder stone. The day prior to the issue the technician for this case, was working with dr. And asked him if the 20-watt dornier would be sufficient for his case the next day, and the doctor confirmed it would be. Prior to the case the laser was test fired as per standard pri policy without incident. Once the pt was scoped the doctor and the technician realized the initial assessment of the stone was underestimated. After 35 - 40 minutes of lasing at nearly maximum power (15-18watts) the laser shutdown with a power failure code 8. The laser was allowed to cool for a few moments and restarted. But the laser would still fault. The technician attempted this a couple more times at lower power settings, but unfortunately it would not stay active for any functional amount of time. The case was finished without the laser and with no injuries to the pt, staff or doctor. The day after the case the technician talked to a nurse at the facility terese ferguson regarding the case. When he spoke to her and recounted exactly what happened with the laser during the case she informed the pri technician that the facility has been experiencing electrical problems. She also informed the tech that the biomed department is working on revamping their electrical systems to prevent a series of equipment issues that they have been experiencing. Pri action taken: the laser was immediately removed from service and returned to our corporate office for inspection. The laser was vigorously inspected and test fired. The laser worked perfectly and required no additional work. The laser has since been used on numerous occasions without incident. Conclusion: a fault 8 is due to insufficient t power. This means the laser was unable to draw the required amount of voltage and or amperage from the wall to produce laser light. Fault 8 can also occur due to extensive use causing overheating. We surmise that due to the underestimated size and or quantity of stones which resulted in extensive lasing at near max energy the laser overheated causing the fault 8. I am also confident that if given sufficient time to cool down the laser would have been restored to full use but due to time constraints in the or that was not possible. It is also possible that the facility electrical problems may have been a contributing factor or the sole factor in the lasers failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5012097
MDR Report Key1423117
Date Received2009-07-27
Date of Report2009-07-27
Date of Event2009-06-24
Date Added to Maude2009-08-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDORNIER MEDLITE 20WATT
Generic NameLASER (LASER TRIPTER)
Product CodeLNK
Date Received2009-07-27
Model NumberMEDLITE 20
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerDORNIER MED TECH AMERICA
Manufacturer Address1155 ROBERTS BLVD KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2009-07-27

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