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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP
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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP Back to Search Results
Model Number 27040GP130-S
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
Product has not been returned by facility, therefore product has not been evaluated.
 
Event Description
Allegedly per the customer, during a turbt procedure, the electrode broke off inside the patient.The broken part of the electrode was safely removed with no harm to the patient.The electrode was replaced and the procedure completed.
 
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Brand Name
CUTTING LOOP, BIPOLAR
Type of Device
BIPOLAR SINGLE USE 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 e. grand avenue
el segundo, CA 90245
4242188201
MDR Report Key10878411
MDR Text Key228436646
Report Number9610617-2020-00129
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393864
UDI-Public4048551393864
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/20/2020
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? No
Device Operator Health Professional
Device Model Number27040GP130-S
Device Catalogue Number27040GP130-S
Device Lot Number37EJ0812
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2020
Initial Date FDA Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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