• 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
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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;
-
-