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

Model Number	26050E
Medical Device Problem Codes	Break (1069); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.Device was returned for investigation and the investigation is pending.
Event or Problem Description
It was reported that there was a breakage within the shaft and corrosion.No negative impact in state of health reported.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the customer's complaint can be confirmed.The working element shows a break directly behind the fixed handle.The reinforcement tube has come loose at the weld seam and has "burst open" as a result.On closer inspection, you can see that the shaft tube inside the reinforcement tube is also broken.You can see that the inner shaft tube is completely corroded, which is the cause of the break.The working element was repaired in april 2015 and labeled with the new solder, which means that the item is already older.The cause of the fault is due to wear and tear.In the reprocessing instruction it is pointed out that the article should always be inspected for external damage and that the article should be completely dried after each reprocessing.The event is filed under internal karl storz 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
• MDR Report Key: 21294700
• Report Number: 9610617-2025-00116
• Device Sequence Number: 9244963
• Product Code: HIH
• UDI-Device Identifier: 04048551092293
• UDI-Public: 04048551092293
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 26050E
• Device Catalogue Number: 26050E
• Device Lot Number: RU06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 03/18/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/14/2025; 04/15/2025
• 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: Unknown