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

Model Number	33310UM
Medical Device Problem Codes	Break (1069); 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 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
It was reported that forceps are found broken after the medical procedure.No negative impact in state of health reported.Cross reference mdr: 9610617-2026-00033, 9610617-2026-00034.
Additional Manufacturer Narrative
The device in question was returned to 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).
Additional Manufacturer Narrative
Correction in device information in section d.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: accordingly, we would like to give a summary of our results regarding the reported issue.The technical investigation revealed a break in the tie rod at the transition to the fork.Analysis of the breakage site showed that the break occurred within the fork structure.This breakage pattern suggests that the tie rod failed not due to normal intended use, but due to excessive force.Due to its design, the tongs insert is guided in an outer shaft, which specifically protects it against lateral forces.Likewise, a defect resulting from the regular gripping process is considered unlikely, as the forces occurring during this process are primarily absorbed by the joint mechanism and no significant tensile or lateral load is exerted on the pull rod 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: 23996307
• Report Number: 9610617-2026-00035
• Device Sequence Number: 10503499
• Product Code: GCJ
• UDI-Device Identifier: 04048551134719
• UDI-Public: 04048551134719
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 03/03/2026

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: 33310UM
• Device Catalogue Number: 33310UM
• Device Lot Number: UM03
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 01/26/2026; 02/24/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/08/2026; 01/29/2026; 03/03/2026
• 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