MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number	33510DU
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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 forceps was inserted into the patient's abdominal cavity.When the forceps was opened, a groove came loose from the inlay and fell into the patient.Since the groove could be removed from the patient immediately, there was no significant delay reported.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during the examination of the article 33510du with the lot number tu01, it was found that the rivet head, which secures the connection between the joint and the jaw part, had broken off.The article is almost 10 years old, which indicates possible material fatigue.The connection between the joint and the jaw is made by a rivet that is welded on one side and held on the other side by the rivet head.The cause of the breakage is likely to be a combination of the following factors: 1.Material fatigue: the service life of the article has most likely been reached after almost 10 years.2.Excessive force: it is possible that the article was subjected to excessive mechanical stress, which accelerated the breakage.3.Corrosion and weakening: slight discoloration can be seen in the broken rivet, indicating possible contamination or corrosion.This could have been caused by microcracks in the rivet that have absorbed moisture, thus weakening the material.Relevant information from the documentation: the reprocessing instructions indicate that the service life of the article is limited.The instructions for use (ifu) recommend checking the instrument for damage before use.In addition, the ifu contains a warning regarding the application of excessive force to the article.Verification of the recommended service life: it should be ensured that instruments of this type are not used beyond their recommended service life.Regular inspection prior to use: a thorough visual inspection of the rivets and joints for signs of cracks or corrosion should be carried out.Conclusion and recommendation: the investigation suggests that the fracture was caused by a combination of natural material aging, mechanical stress and possibly favoring corrosion.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: CLICKLINE FORCEPS INSERT
• 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: 21219235
• Report Number: 9610617-2025-00045
• Device Sequence Number: 19677537
• Product Code: GCJ
• UDI-Device Identifier: 04048551151044
• UDI-Public: 04048551151044
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/21/2025

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: 33510DU
• Device Catalogue Number: 33510DU
• Device Lot Number: TU01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/21/2025
• 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