MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CORD,HI FREQ,W/8MM PLUG,300CM,; HI FREQUENCY CORD

Model Number	279KB
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer does not know where the cord is or where on the cord it arced.They do not expect they will return the cord.
Event or Problem Description
Allegedly, there was a spark noticed when using the cord inside the patient during a procedure.It was reported there was no harm to the patient.

• Brand Name: CORD,HI FREQ,W/8MM PLUG,300CM,
• Common Device Name: HI FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8565987
• Report Number: 9610617-2019-00042
• Device Sequence Number: 13524194
• Product Code: GEI
• UDI-Device Identifier: 04048551090862
• UDI-Public: 4048551090862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: 279KB
• Device Lot Number: ZS01
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/30/2019
• 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: Other
• Patient Age: 54 YR