KARL STORZ 11301BN1 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-12-19 for KARL STORZ 11301BN1 NA manufactured by Karl Storz Endovision.

Event Text Entries

[19198922] Allegedly, based on a vigilance report filed with (b)(4) by our parent company in (b)(6), 5 patients became infected with kiebsiella 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 unk. 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 pt #5.
Patient Sequence No: 1, Text Type: D, B5


[19389552] After the events, (b)(4) 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 hfgh 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 bacterial results were negative. Karl storz-(b)(4) eval: the flexible endoscope was delivered to karl storz (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 mfr.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1221826-2013-00056
MDR Report Key3565579
Report Source01,06,07
Date Received2013-12-19
Date of Report2013-11-20
Date of Event2013-11-15
Date Mfgr Received2013-11-20
Device Manufacturer Date2013-05-01
Date Added to Maude2014-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSUSIE CHEN
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 902455017
Manufacturer CountryUS
Manufacturer Postal902455017
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ ENDOVISION
Manufacturer Street91 CARPENTER HILL RD.
Manufacturer CityCHARLTON MA 01507
Manufacturer CountryUS
Manufacturer Postal Code01507
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKARL STORZ
Generic NameINTUBATION SCOPE
Product CodeCAL
Date Received2013-12-19
Model Number11301BN1
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ ENDOVISION
Manufacturer AddressCHARLTON MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-12-19

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