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

Model Number	33310C
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
Result of investigation: the product has been returned for investigation and could be identified as a karl storz product.Most probable root cause: operating error due to overloading.One of the branches of the returned item has broken off.Due to the application of excessive force during the setting process, the branch bent so far that it subsequently broke.This can be seen from the raised material at the break edge.In addition, the material may have been weakened by the number of applications and reprocessing (produced in may 2010).According to the ifu 97000025; version:4.2 - 02/2020 functionality should always be checked before and after every use to avoid injuries and damages to the product.Damaged instruments must not be used.Furthermore, the cleaned and disinfected medical device must be visually inspected for cleanliness, completeness, damages and corrosion, visible contamination and dryness (chapter 8).In addition, overloading and exerting to much force can cause the medical device to break, bend or malfunction.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the end of the laparoscopic desolater snapped off.No negative impact in state of health reported.There is no material number given, it is only known that the involved device is a "laparoscopic desplanter".Since the exact material number is unknown, a further evaluation cannot be conducted as it is not confirmed that karl storz is the legal manufacturer of the device.Due to the reasons stated above no further assessment regarding reportability obligation possible.Version bb: during file review on may 23, 2025 it turned out that the material number is given in the meantime.Thus, the dq must be updated.

• 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: 22124780
• Report Number: 9610617-2025-00955
• Device Sequence Number: 8669637
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 04048551134092
• 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
• Report Date (Section B): 06/02/2025

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: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: SZ 3/10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/02/2025
• 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