MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE,DISSECTING,L-SHAPED; DISSECTING ELECTRODE

Model Number	26870UFS
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not returned product 26870ufs for evaluation.Per the customer, the date code was pr03 which indicates the product was manufactured 03/2018 and it was shipped to the customer approximately 1 year ago.
Event or Problem Description
Allegedly, it was reported the l hook insulation was damaged prior to use and it sparked and burned the patient's skin.The burn was noticed after the procedure.

• Brand Name: ELECTRODE,DISSECTING,L-SHAPED
• Common Device Name: DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8689542
• Report Number: 9610617-2019-00055
• Device Sequence Number: 2298992
• Product Code: GEI
• UDI-Device Identifier: 04048551072578
• UDI-Public: 4048551072578
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K944796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 26870UFS
• Device Lot Number: PR03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/11/2019
• 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