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 61872 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
  • 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 61872 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE Back to Search Results
Model Number 011050-10
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/03/2023
Event Type  Injury  
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
According to the complaint description the device broke during use whilst trying to remove large fibroid.Piece is still inside patient and they are trying to remove from patient.The broken part is still in patient and a additional/prolonged hospitalization was necessary.
 
Manufacturer Narrative
The initial mdr was submitted as an importer by mistake.This supplemental report contains all the correct information intended for the initial report.The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event Description
According to the complaint description the device broke during use whilst trying to remove large fibroid.Piece is still inside patient and they are trying to remove from patient.The broken part is still in patient and a additional/prolonged hospitalization was necessary.
 
Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
 
Manufacturer Narrative
The product was returned on 2023-11-23.The investigation of the product was completed on 2024-02-26.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.The problem described by the customer can be confirmed.Due to the ductile appearance of the broken surface and the overall bending of the device, it is most likely that the cutting loop got mechanically overloaded during application.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
61872 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
Type of Device
ELECTRODE, BIPOLAR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM   78532
Manufacturer Contact
anja fair
2151 e grand ave
el segundo, CA 90245
MDR Report Key18184874
MDR Text Key328701018
Report Number9610617-2023-00376
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K882270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/21/2023,03/05/2024
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 Health Professional
Device Model Number011050-10
Device Catalogue Number011050-10
Device Lot Number847099
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/16/2023
Event Location Hospital
Date Report to Manufacturer11/21/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/21/2023
Supplement Dates Manufacturer Received11/03/2023
11/23/2023
02/26/2024
Supplement Dates FDA Received11/21/2023
12/18/2023
03/06/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-