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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR
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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR Back to Search Results
Model Number 27040GP1-S
Device Problem Material Integrity Problem (2978)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
Item was found the tip melted off, insulation was melted, and the proximal end is bent.This type of occurrence most likely is related to esg setting, and mechanical force.
 
Event Description
Allegedly, the cutting loop broke off in a patient.No further information is available.
 
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Brand Name
CUTTING LOOP, BIPOLAR, 24/26 FR
Type of Device
CUTTING LOOP
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 Key10915789
MDR Text Key218576068
Report Number9610617-2020-00136
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393482
UDI-Public4048551393482
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K962030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/28/2020
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 No Information
Device Model Number27040GP1-S
Device Lot NumberNP63
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2020
Initial Date FDA Received11/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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