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
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
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).

• 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
• MDR Report Key: 25260825
• Report Number: 2020550-2026-01168
• Device Sequence Number: 14826791
• Product Code: GCJ
• UDI-Device Identifier: 04048551134108
• UDI-Public: 04048551134108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026
• Report Date (Section F): 05/22/2026

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown