MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT

Model Number	27050E
Medical Device Problem Codes	Sparking (2595); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during turp case in (b)(6) 2024 (exact date was not provided), the resectoscope handpiece made sparks and caused the side to melt internally, and a dark spot to form.They were able to complete the procedure using a back-up device with no delay.No patient impact was reported.
Additional Manufacturer Narrative
Additional information: the device was returned to our us facility on oct-23-2024, section d9 was updated with this information.The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per evaluation conducted by the manufacturing site: result of investigation: the defect identified is most likely due to improper use by the user.Thermal damage was identified in the white teflon block, which was caused by heat generation inside the device.Possible causes of this heat generation could be a short circuit, a flashover or similar electrical malfunctions.One possible reason for a short circuit is the presence of residual moisture inside the device, which can ultimately lead to a burn-through of the teflon block.In addition, it was determined that the article with the lot number pt04 was produced in 2016.This means that the product is already 8 years old, which indicates that a possibly reached life cycle could also have contributed to the defect.The combination of aging and electrical influences could thus be the cause of the described error.Here it is important that the user adheres to the instructions for use in order to avoid defects.This event is filed under internal complaint id (b)(4).

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• 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 ; 4242188247
• MDR Report Key: 20424335
• Report Number: 9610617-2024-00377
• Device Sequence Number: 18107915
• Product Code: FDC
• UDI-Device Identifier: 04048551077542
• UDI-Public: 04048551077542
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

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: 27050E
• Device Catalogue Number: 27050E
• Device Lot Number: PT04
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 12/11/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/26/2024; 12/17/2024
• 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
• Patient Sex: Male