MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING ELECTRODE, STERILE, 24FR; 24FR ELECTRODE

Model Number	27040G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken electrode has not been returned for evaluation.
Event or Problem Description
Allegedly, during a procedure, the loop of the electrode broke off into the patient.They were able to retrieve it; there was no harm to patient.

• Brand Name: CUTTING ELECTRODE, STERILE, 24FR
• Common Device Name: 24FR ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8026803
• Report Number: 9610617-2018-00087
• Device Sequence Number: 19105902
• Product Code: HIH
• UDI-Device Identifier: 04048551393246
• UDI-Public: 4048551393246
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040G
• Device Catalogue Number: 27040G
• Device Lot Number: 37GH1729
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1