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

Model Number	33510FS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the opening and closing mechanism failed and the locking element of the insert was missing during surgery.The part was found on the scrub trolley.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information has been provided.The surgey was delayed less than 15 minutes, no part fell in situ, and no additional medical intervention was necessary.There were no consequences for the patient.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation, the lot number has been provided in section d4, and the manufacturing date has been updated in section h4.Section b5 has been updated with additional information.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: investigation of the device revealed that the insert, which is locked in place by two hooks in the bayonet of the outer shaft, was fallen off.One of the two hooks is broken off and the other is severely bent.This may have been caused by mechanical impact.In addition, the item was manufactured in 2016, so it can be assumed that it has been used and reconditioned a corresponding number of times.The most probable root cause is wear and tear.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
• MDR Report Key: 22287965
• Report Number: 9610617-2025-01061
• Device Sequence Number: 8374307
• Product Code: GCJ
• UDI-Device Identifier: 04048551151068
• UDI-Public: 04048551151068
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/16/2025

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: 33510FS
• Device Catalogue Number: 33510FS
• Device Lot Number: NT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 11/24/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/23/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2016
• 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