MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR COAGULATING; ENT, COAGULATING ELECTRODE

Model Number	840036E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned and we found the distal tip was separated from the electrode.The date code august 2005, indicates 14 years in service which can cause wear and breakage of the instrument.
Event or Problem Description
Allegedly, during a laryngoscopy when pulling out the electrode the doctor noticed the tip was missing.Per the nurse manager, "the doctor was able to remove the tip in it's entirety, the case completed with no harm to patient".

• Brand Name: ELECTRODE, BIPOLAR COAGULATING
• Common Device Name: ENT, COAGULATING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 8836800
• Report Number: 9610617-2019-00062
• Device Sequence Number: 10842397
• Product Code: EOB
• UDI-Device Identifier: 04048551207826
• UDI-Public: 4048551207826
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840036E
• Device Catalogue Number: 840036E
• Device Lot Number: HE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 86