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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; LASER FOR GASTRO-UROLOGY USE
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; LASER FOR GASTRO-UROLOGY USE Back to Search Results
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
Holmium laser that urology uses was checked and tested by biomed, and witnessed by charge nurse that day.According to biomed the holmium laser can safely be used for today's case.Circulator and scrub nurse turned the laser machine on for 9 seconds prior to bringing patient back into the room.I saw the laser machine stated pass on the screen, and screen was visible but as soon as the laser handpiece was screwed in the machine the screen turned black (not able to see anything).Team unplugged the machine, we also turned the machine off and waited a few minutes before turning it on several times, we called biomed and biomed came to look at the machine, we also called the rep to ask for advice and to troubleshoot the machine but to no avail, we also notified our nurse manager as well as charge nurse.The surgical team was not able to remove the stones and placed a jj ureteral stent on the right ureter.Patient has to be rescheduled for another date to remove the stones.
 
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Type of Device
LASER FOR GASTRO-UROLOGY USE
MDR Report Key17009473
MDR Text Key316023372
Report Number17009473
Device Sequence Number1
Product Code LNK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/28/2023,03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2023
Event Location Hospital
Date Report to Manufacturer05/26/2023
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25550 DA
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