Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP Back to Search Results
Model Number 27040GP130-S
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product has not been returned by facility, therefore product has not been evaluated.
 
Event or Problem 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CUTTING LOOP, BIPOLAR
Common Device Name
BIPOLAR SINGLE USE CUTTING LOOP
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm
MDR Report Key10878411
Report Number9610617-2020-00129
Device Sequence Number2829270
Product Code FAS
UDI-Device Identifier04048551393864
UDI-Public4048551393864
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K061541
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 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
Operator of Device Health Professional
Device Model Number27040GP130-S
Device Catalogue Number27040GP130-S
Device Lot Number37EJ0812
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/22/2020
Initial Report FDA Received Date11/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-