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

Model Number	33300M
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the 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).
Event or Problem Description
It was reported that the tip of the sheath fell off.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, "the tip of the sheath fell off.", could be confirmed.The article was manufactured according to the current specifications.A design fault was found to be the cause.Since the cut surface is too small, the design of the shaft will be revised by extending the sleeve.The corresponding instruction for use ifu tbf102_en_v2.0_04-2024_ce-mdr contains the following notes in chapter 3.2 "correct handling and product testing": if the product is not handled correctly, patients, users, and third parties may be injured.Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it.Check that the product is suitable for the procedure prior to use.Check the product for the following properties, for example, before and after every use: functionality, damage, changes to the surface, in the case of several components: completeness and correct assembly.Do not continue to use damaged products.Dispose of the product properly; see disposing of the product.Do not leave broken-off components inside the patient.Do not overload the product with mechanical stress.Do not bend bent products back to their original position.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
• MDR Report Key: 23011406
• Report Number: 9610617-2025-01571
• Device Sequence Number: 21472590
• 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): 01/20/2026

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: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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