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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA SUCTION & COAGULATION
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KARL STORZ SE & CO. KG CANNULA SUCTION & COAGULATION Back to Search Results
Model Number 37370DL
Device Problem Material Fragmentation (1261)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
The evaluation found the tip of the electrode is broken, the application tip has not been sent in.The shaft is bent at the end.Furthermore, the shaft has several scratches and dents.Presumably the electrode was bent and bent back.No indication of a material or manufacturing defect found during investigation.The root cause is most likely overloading of the instrument due to excessive force.
 
Event Description
Per the factory in (b)(4), allegedly there was an event which occurred in (b)(6) that the hook broke off and was intraoperative.
 
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Brand Name
CANNULA SUCTION & COAGULATION
Type of Device
CANNULA
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
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key9634181
MDR Text Key194178271
Report Number9610617-2020-00007
Device Sequence Number1
Product Code KNF
UDI-Device Identifier04048551155653
UDI-Public4048551155653
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K944862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number37370DL
Device Lot NumberZR01
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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