MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE PLASTIC HANDLE

Model Number	33126
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 handles of the product broke and snapped away there is no information that the event caused a harm or serious injury to patient, user or third.New information was provided that the issue occurred during use.It was reported that the clickline handle broke during the procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).Result of investigation: the customer's fault description can be confirmed.Part of the rigid handle has broken off.The handle is broken at the point with the smallest cross-section.The handle is broken in a place with a very narrow cross-section.Due to the number of uses/reprocessings that can be assumed based on age (manufactured in august 2014), the plastic can change its material properties due to the cleaning agents/chemicals.This can lead to the material breaking.The point of fracture is also located at a very small cross-section, which can result in correspondingly high forces.The ri points out that a visual inspection and functional check should be carried out before each use.Conclusion: the breakage is due to the age of the article and the associated number of reprocessings as well as the mechanical impact of the user.

• Brand Name: CLICKLINE PLASTIC HANDLE
• Common Device Name: CLICKLINE PLASTIC HANDLE
• 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: 21180389
• Report Number: 9610617-2025-00029
• Device Sequence Number: 4299632
• Product Code: GCJ
• UDI-Device Identifier: 04048551125113
• UDI-Public: 04048551125113
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/25/2025

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: 33126
• Device Catalogue Number: 33126
• Device Lot Number: VV01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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