MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE METAL OUTER SHEATH

Model Number	33300M
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the sheath feil off.There is no information that the event caused a harm or serious injury to patient.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: examination of item 33300m (lot tl07) shows that the glued-in socket at the distal end has come loose.Adhesive residue on the shaft confirms that it was properly assembled.There are no indications of a manufacturing defect.The detachment is most likely due to improper reprocessing for example, through the use of unauthorized chemicals or deviations from the recommended sterilization parameters (134-137°c, 3-18 minutes).The damage is attributable to user error.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE METAL OUTER SHEATH
• Common Device Name: CLICKLINE METAL OUTER SHEATH
• 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: 22797213
• Report Number: 9610617-2025-01412
• Device Sequence Number: 12840781
• Product Code: GCJ
• UDI-Device Identifier: 04048551133965
• UDI-Public: 04048551133965
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K935071
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 33300M
• Device Catalogue Number: 33300M
• Device Lot Number: TL07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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