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

Model Number	33310C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
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
According to the information received, during a laparoscopic bowel resection the tip of the 33310c clickline forceps insert broke/came off.The broken tip was successfully retrieved under x-ray guidance with no injury to the patient.
Additional Manufacturer Narrative
Additional information: the conclusion was based on a previous complaint investigation.The affected item, 33310c clickline forceps insert, lot: tu12, was not returned and therefore unavailable for analysis.During an earlier investigation on a comparable complaint, slight changes in the material were observed at the fracture site.These changes showed similarities to corrosion patterns.It was determined that one side of the jaw at the distal end of the affected instrument had broken off.This may have been caused by microcracks in the material, which in turn could have resulted from extensive use of the instrument.The affected item 33310c clickline forceps insert, lot: tu12 was manufactured in june 2015, meaning the product is approximately 10 years old.Therefore, the most likely root cause is that repeated chemical reprocessing cycles combined with mechanical usage cycles contributed to material fatigue, ultimately leading to jaw breakage under load during use.The reprocessing instruction ri.33310c_en_v36.1_07[?]2022_ri_ce states the following in section 11 "life span": the service life of the product is largely determined by wear, reprocessing procedures, the chemicals used, and any damage resulting from use.Assuming proper and professional use and reprocessing, karl storz has validated electrical safety for a total of 400 cycles.In addition the ifu 97000025, version 4.2 - 02/2020 contains the following note (page 2 & 3): "warning: risk of injury: incorrectly assembled and damaged instruments can lead to injuries to the patient.Instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage, and in full working order and have no unintentional rough surfaces, sharp corners, burred edges or projecting parts.Care must be taken not to leave missing or broken-off components inside the patient." "warning: risk of injury: overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions." the conducted investigations did not reaveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.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: 23791640
• Report Number: 9610617-2025-02324
• Device Sequence Number: 5546451
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 04048551134092
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 33310C
• Device Catalogue Number: 33310C
• Device Lot Number: TU12
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown