MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR; BIPOLAR HIGH FREQUENCY CORD

Model Number	27040DB
Medical Device Problem Codes	Sparking (2595); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the working element and lead sparked during the case.It has been confirmed that the electrode was inside the patient when the incident occurred, they stopped the procedure straightway.No harm to the patient or the surgeon was noted.Another system was used to complete the procedure right after the incident.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the products were returned for evaluation.The investigation is not completed yet.The investigation results are pending.Additioanl informationw is provided to include the concomitant products in section d10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The examination of the different articles revealed the following.The article 27040db shows signs of use such as soiling, but no serious damage that would lead to impairment of function or total failure.This item is therefore excluded as the cause of the complaint.The article uh400e/autocon as well as the uf902 / two -pedal are also excluded as the cause of the complaint because the article uh400 provides the necessary current flow / voltage and the article uf902 foot switch releases this to the instrument and the information from the customer indicates that the cause is another.Here it could be determined in the direction of article uh801 that the cable on the device plug has a small mechanical damage.This damage could lead to a high current resistance and consequently to sparks or flames at the connection.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: BIPOLAR HIGH FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19384671
• Report Number: 9610617-2024-00149
• Device Sequence Number: 20601019
• Product Code: FAS
• UDI-Device Identifier: 04048551075500
• UDI-Public: 4048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2024

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: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: ON14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 08/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/05/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UF902 - TWO-PEDAL FOOTSWITCH HF GENERATORS.; UH400E - AUTOCON III 400 CE, 220-240V.
• Patient Sex: Unknown