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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO.; LED LIGHT SOURCE

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KARL STORZ GMBH & CO.; LED LIGHT SOURCE Back to Search Results
Lot Number 0002
Device Problem Overheating of Device (1437)
Patient Problem Blister (4537)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
2 blisters secondary to light cord activation.Nursing, periop nursing, notified documented and protocol initiated.I spoke to the patient's husband and explained, showed images.His main concern was being upset that he heard a code red called over public address (pa) system in room and thought there was a fire.I reassured him.Code red was called after completion of surgery and 25 minutes after we identified injury.
 
Event Description
Two blisters secondary to light cord activation.Nursing, periop nursing, notified documented and protocol initiated.I spoke to the patient's husband and explained, showed images.His main concern was being upset that he heard a code red called over public address (pa) system in room and thought there was a fire.I reassured him.Code red was called after completion of surgery and 25 minutes after we identified injury.
 
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Type of Device
LED LIGHT SOURCE
Manufacturer (Section D)
KARL STORZ GMBH & CO.
2151 e. grand avenue
el segundo CA 90245
MDR Report Key11723690
MDR Text Key247278140
Report Number11723690
Device Sequence Number1
Product Code NTN
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,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2021
Event Location Hospital
Date Report to Manufacturer04/26/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25915 DA
Patient Weight55
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