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

Model Number	33121
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during a surgical gynaecology laparoscopic procedure, a piece of the non-ratchet handle snapped off and fell onto the patient.Surgeon managed to obtain this and give to the scrub nurse.Another non-ratchet handle was assembled and the procedure carried on.Nurse in charge informed.Sterile services to be informed.A replacement handle to be sourced.Patient was not harmed - alternative instrumentation sourced and procedure completed without further event." no negative impact in state of health reported.
Additional Manufacturer Narrative
The device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 24225425
• Report Number: 9610617-2026-00174
• Device Sequence Number: 13102879
• Product Code: GCJ
• UDI-Device Identifier: 04048551001097
• UDI-Public: 04048551001097
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 33121
• Device Catalogue Number: 33121
• 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: 01/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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