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

Model Number	33300M
Medical Device Problem Code	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 internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that the tip of the outer sheath comes off.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: it can be seen that one side of the bayonet lock is minimally bent.The lock was checked by means of a clickline insert (insert distally and lock by turning 90 degrees); this worked perfectly.Since the proximal insert locks into place in the handle, it is not possible for the insert to fall out if it is correctly installed.On the shaft 33300m, one side of the bayonet lock can be seen to be bent slightly towards the center (fig.2).After checking with a clickline insert, however, no malfunction can be detected and the insert can be locked without problems.A possible cause for the customer's problem is that the shaft, together with the insert, is not properly locked in the handle and thus could come loose from the shaft.(when everything is assembled in a "set", no component can come loose).As described in the ifu, the set must be checked for function before each use; a malfunction would have been detected.The slightly bent bayonet has no effect on the function of the article.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: 21274743
• Report Number: 9610617-2025-00092
• Device Sequence Number: 8157345
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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