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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO- RENOSCOPE SEMI-RIGID URETEROSCOPE

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KARL STORZ SE & CO. KG URETERO- RENOSCOPE SEMI-RIGID URETEROSCOPE Back to Search Results
Model Number 27010KA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 04/19/2018
Event Type  Injury  
Manufacturer Narrative
Customer indicated that scope did not malfunction and there was no physical issue with it. The sem-rigid scope was returned for microbial testing, since customer believes that scope may have been involved with a patient infection. The rigid endoscope (serial no. (b)(4)) was received one (b)(6) 2018 at karl storz logistic center in (b)(4). Once received, the channels of the endoscope were sampled by performing a flush-brush-flush technique with sterile water and a new cleaning brush to recover any potential contamination inside the device. The sterile water from the channels was collected in a sterile sample cup and a negative control sample was prepared using the same lot of sterile water, cleaning brush, and a sample cup. The sample from the device was labeled as "(b)(4)" while the negative control sample was labeled as "(b)(4)". The samples were then shipped to nelson labs for microbial analysis. Membrane filtration of the samples yielded no detectable colony forming units (cfus). Therefore, no contamination was detected within the channels of the rigid endoscope.
 
Event Description
Allegedly, the doctor performed a ureteroscopy with left laser lithotripsy and stent placement on a patient. Post procedure, the patient was experiencing fever and chills. Patient went to the er and was found to have an infection and was treated with augmentin- antibiotics. As per the hospital, the patient is recovering well.
 
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Brand NameURETERO- RENOSCOPE
Type of DeviceSEMI-RIGID URETEROSCOPE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl storz-strasse 34
tuttlingen 78532
GM 78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.- karl storz-strasse 34
tuttlingen, 78532
GM 78532
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key7623587
MDR Text Key111815435
Report Number9610617-2018-00043
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K940464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number27010KA
Device Catalogue Number27010KA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2016
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: 06/20/2018 Patient Sequence Number: 1
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