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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. KARL STORZ INTUBATION SCOPE

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KARL STORZ ENDOVISION, INC. KARL STORZ INTUBATION SCOPE Back to Search Results
Model Number 11301BN1
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802); Unspecified Infection (1930)
Event Date 11/15/2013
Event Type  Death  
Manufacturer Narrative
After the events, (b)(6) hospital's testing results confirmed that scope contained resistant microbes (klebsiella pneumoniae). Our investigation of events confirmed that an incorrect, undersized cleaning brush was used on the scope before olympus aer high level disinfection process. Hospital was informed regarding correct cleaning brush. The hospital replaced this brush with the correct sized cleaning brush and processed scope again. Scope was tested afterwards by hospital's infection control department for bacteria; results were negative. Karl storz-(b)(4) evaluation: the flexible endoscope was delivered to karl storz (b)(4) on (b)(4). Upon investigation, we couldn't find any damages or leakages. The instrument channel shows no deformations, scratches or other damages that could trap debris as a potential root cause. There is no indication detectable that the endoscope itself was the root cause of the infections. After appropriate reprocessing according to the ifu, the endoscope is free of microorganism. The device will be sent back to manufacturer.
 
Event Description
The data and information contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary information received by karl storz, who has not conclusively determined the cause of the adverse event. This mdr is, therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any karl storz products were caused related to the incident. Allegedly, based on a vigilance report filed with (b)(6) by our parent company in (b)(4), 5 patients became infected with klebsiella pneumoniae microbes after intubations done with this scope. Three patients expired after being infected, although there is no causal link established between infection and outcome. Outcome of 2 other infected patients unknown. We will list patients who expired as patient #1, #2, and #3. The 2 patients who were infected but did not expire, are listed as patients #4 and #5. This report is regarding patient #1.
 
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Brand NameKARL STORZ
Type of DeviceINTUBATION SCOPE
Manufacturer (Section D)
KARL STORZ ENDOVISION, INC.
charlton MA
Manufacturer (Section G)
KARL STORZ ENDOVISION
91 carpenter hill rd.
charlton MA 01507
Manufacturer Contact
susie chen, complaint
2151 e. grand ave.
el segundo, CA 90245-5017
4242188201
MDR Report Key3565551
MDR Text Key11365622
Report Number1221826-2013-00052
Device Sequence Number1
Product Code CAL
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11301BN1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
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: 12/19/2013 Patient Sequence Number: 1
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