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

Model Number	33310CC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Laceration(s) (1946)
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
It was reported while using the 33310cc, the doctor tore the intestine and caused bleeding when grasping intestinal tissue.Instrument inspection revealed that the product surface was rough, which is prone to causing intestinal tissue bleeding during grasping.Furthermore it was stated it is intestinal tissue injury.The clinician believes that the injury may also be related to the patient's advanced age and fragile intestinal tissue, but this cannot be confirmed.Moreover, rc inspection revealed that the device surface was not significantly rough.The surgeon promptly performed suturing on the lacerated bowel tissue.
Additional Manufacturer Narrative
Additional information: 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).

• 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: 25260828
• Report Number: 9610617-2026-01168
• Device Sequence Number: 5496331
• Product Code: GCJ
• UDI-Device Identifier: 04048551134108
• UDI-Public: 04048551134108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/29/2026

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: 33310CC
• Device Catalogue Number: 33310CC
• Device Lot Number: ZS46
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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; Required Intervention
• Patient Sex: Unknown