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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT SOURCE, 300 WATT XENON W/SCB

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KARL STORZ ENDOVISION LIGHT SOURCE, 300 WATT XENON W/SCB Back to Search Results
Model Number 201331-20-1
Device Problem Use of Device Problem (1670)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
The light source was returned and evaluated; our findings were as follows: all output readings are below spec. Unit was received in with a different lamp installed than what our records show we installed when we last serviced the light source in july 2016; also, the lamp differs from what karl storz recommends. Lamp output is not meeting spec. Lumen reading: 1113 actual; spec rating 1530-2800. Optical power 1. 9 actual; spec rating 5. 1 max. In addition, the model numbers for the light cable and arthroscope used for the procedure, which were provided to us by the hospital, are not of our manufacturer; the light cable, model #wa03310a, we believe is an olympus light cable; the arthroscope, model #502104030, is a stryker model number. There was no reported malfunction of the light source. The burn injury most likely occurred as a result of the light cable's connector coming into contact with the patient.
 
Event Description
Allegedly, the patient sustained a 3rd degree burn under her arm during a rotator cuff arthroscopy procedure; the burn was noticed by the patient the day after the procedure.
 
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Brand NameLIGHT SOURCE, 300 WATT XENON W/SCB
Type of DeviceLIGHT SOURCE
Manufacturer (Section D)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer (Section G)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key7986369
MDR Text Key124476851
Report Number1221826-2018-00082
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201331-20-1
Device Catalogue Number201331-20-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/19/2018 Patient Sequence Number: 1
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