MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MONOPOLAR HIGH FREQUENCY CORD WITH 5MM PLUG

Model Number	277KE
Medical Device Problem Codes	Circuit Failure (1089); Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is currently under investigation.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): patient positioned in lithotomy position and prepared for tur; bleeding occurred in (b)(6), current suddenly could not be triggered, bleeding could not be stopped even with 2nd prepared instrument (also no current flow ensured).Due to this and to further reduce patient's damage, procedure had to be changed to open surgery.This report is for the first instrument that failed during the procedure.
Additional Manufacturer Narrative
The cable lot xr01 was returned to manufacturer on 08 march 2021 for investigation.After testing, we confirmed that the cable is broken and there is no current running through the cable.Furthermore, it can be seen that the cable was bent, which can be the reason for the inner wire to break or disconnect.The root cause of no function during use is most likely due to use error by bending the cable with too much force, causing the wires to break.

• Brand Name: MONOPOLAR HIGH FREQUENCY CORD WITH 5MM PLUG
• Common Device Name: HIGH FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11565739
• Report Number: 9610617-2021-00028
• Device Sequence Number: 4767284
• Product Code: GEI
• UDI-Device Identifier: 04048551090206
• UDI-Public: 4048551090206
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K945380
• 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
• Report Date (Section B): 03/12/2021

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: 277KE
• Device Catalogue Number: 277KE
• Device Lot Number: XR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: Other