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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM

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KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM Back to Search Results
Model Number 27026EF
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
As per manufacturer incident report (b)(4) received from the factory in germany: it was reported that the distal end of the catheter deflecting mechanism broke off during the procedure.The broken off part has not been found and an x-ray was taken without detecting the missing part in the patient.The broken off part could have remained in the patient's body.
 
Manufacturer Narrative
The affected device was requested for further investigation, but not returned yet.
 
Manufacturer Narrative
The device was evaluated on july 1st 2022.According to the visual inspection, the shaft is bent and traces of corrosion are visible on the entire instrument.It could be confirmed that the separated part of the insturment is missing.Based on the damage patterns and the investigation results, the most probable root cause is due to incorrect reprocessing, as the instrument was not properly dried.
 
Event Description
As per additional details provided in the final manufacturer incident report # (b)(4).Received from the factory in germany: the procedure was prolonged by approximately 10 mins as patient drapes, scrub trolley operating table and surrounding area checked.The actual operation results do not deviate from the planned operation results.
 
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Brand Name
CATHETER DEFLECTING MECHANISM
Type of Device
CATHETER DEFLECTING MECHANISM
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM  
Manufacturer Contact
anja fair
2151 e grand ave
el segundo, CA 90245-5017
4242188738
MDR Report Key14653495
MDR Text Key294046176
Report Number9610617-2022-00089
Device Sequence Number1
Product Code ODB
UDI-Device Identifier04048551231876
UDI-Public4048551231876
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K943697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27026EF
Device Catalogue Number27026EF
Device Lot NumberPR04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/23/2022
Initial Date FDA Received06/10/2022
Supplement Dates Manufacturer Received07/01/2022
Supplement Dates FDA Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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