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

Model Number	33310CC
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the surgical procedure, the curved fenestrated clamp presented a problem, where the internal stem came loose from the tube after insertion into the abdominal cavity.No negative impact in state of health reported.
Additional Manufacturer Narrative
Lot number of the device is updated, as documented in section d9.Device evaluation: the items examined as part of the complaint (33310cc - lot rm25, 33121 - lot wm27, 33300 - lot um22) show signs of wear but are in working order.The defect described by the customer (the detachment of the inner shaft from the outer tube during a surgical procedure) could not be reproduced under controlled conditions, either individually or as a set.No technical or structural defects were found that would explain the reported incident.Based on the tests performed and the lack of reproducibility of the defect, a production-related error is unlikely.It is possible that the incident was due to an application-related deviation or a one-time mechanical stress during the procedure.This event is filed under internal 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
• 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: 22099012
• Report Number: 9610617-2025-00929
• Device Sequence Number: 7357027
• Product Code: GCJ
• UDI-Device Identifier: 04048551134108
• UDI-Public: 04048551134108
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/21/2025

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: 33310CC
• Device Catalogue Number: 33310CC
• Device Lot Number: RM25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 33300 METAL OUTER SHEATH, INSULATED, 36,LOT: UM22; ARTICLE:33121 - CLICKLINE PLASTIC HANDLE,LOT: WM27
• Patient Sex: Unknown