MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR DISSECTION ELECTRODE, 5 FR; BIPOLAR DISSECTING ELECTRODE

Model Number	26159BE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device currently under investigation: no results available so far.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the electrode was loosened during the surgery.The electrode stayed in the patient.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
Upon evaluation the breakage of the electrode tip could be confirmed.The broken off piece was not returned.There are visible usage marks and scratches on the instrument.Furthermore, there are signs of corrosion at the breakage area.The root cause most likely is unintended mechanical damage during use.The damage of the product is not caused by a production problem or material defect.

• Brand Name: BIPOLAR DISSECTION ELECTRODE, 5 FR
• Common Device Name: BIPOLAR DISSECTING ELECTRODE
• 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 90245-5017 ; 4242188201
• MDR Report Key: 11151528
• Report Number: 9610617-2021-00003
• Device Sequence Number: 3920298
• Product Code: GCJ
• UDI-Device Identifier: 04048551094228
• UDI-Public: 4048551094228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: 26159BE
• Device Catalogue Number: 26159BE
• Device Lot Number: NP07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/12/2020; 08/10/2022
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 08/08/2022; 08/11/2022
• Date Device Manufactured: 01/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown