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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG STORZ; LED LIGHT SOURCE
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KARL STORZ GMBH & CO. KG STORZ; LED LIGHT SOURCE Back to Search Results
Model Number TL300
Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
Storz power led 300, tl 300 light source being used with 5mm laparoscope & light cord to perform 'scope' surgery of pelvis.Towards the end of the case, the light source unexpectantly became disconnected and burned a hole through the drapes.This resulted in ~5mm diameter burn to patient¿s left chest.Manufacturer response for storz light source and cable, (brand not provided) (per site reporter): we have made the manufacturer aware of the increase in light source events over the last several months.The on-site vendor representative has stated there have been no design changes to the storz product.
 
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Brand Name
STORZ
Type of Device
LED LIGHT SOURCE
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG
2151 e. grand avenue
el segundo CA 90245
MDR Report Key11677559
MDR Text Key245807662
Report Number11677559
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
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTL300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Event Location Hospital
Date Report to Manufacturer04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age10950 DA
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