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

Model Number	33410ON
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Perforation (2001); Insufficient Information (4580)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the atraumatic grasper created a tear/hole on the stomach, and it was not being pulled on.The surgeon said that she would have needed to suture the holes, had that part of the stomach remained inside the patient.Fortunately, it was the part of the stomach that was removed from the body.The surgeon mentioned that it happened in another case a week or two ago.Cross reference mdr 9610617-2025-00242.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on march 4,2025.This information is reflected in section d9.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation findings by the manufacturing site: according to the customer complaint: "using product 33410on (batch op08) caused a lesion in the stomach area".According to the user, it was a tear or hole that was probably caused by the atraumatic gripper.The subsequent technical examination of the returned product revealed no evidence of manufacturing or design defects.Visual and microscopic inspection showed that the edges of the mouthpiece were cleanly broken and partially rounded.No sharp edges or burrs were found on or between the teeth.Even under magnified examination, no signs of manufacturing defects could be identified.The results confirm that the product was manufactured in accordance with the applicable quality standards.During the analysis, it was found that the pull rod was significantly bent in the upper and lower areas.As the pull rod must be straight due to its design, this deformation is considered atypical.Due to the material properties and mechanical stability of the component, it can be assumed that the bending was caused by excessive force during use.Such deformation is not to be expected under normal conditions of use.According to our system documentation, this complaint is the first reported complaint about this specific item.Given the overall unremarkable product performance, this is therefore to be regarded as an isolated case that does not indicate a fundamental quality or design problem.It should also be noted that the instructions for use supplied with the product contain detailed information on safe and proper use.Correct handling is essential to minimize application-related risks e.G.Ifu: 97000025 v4.2-02/2020.Warning: risk of injury and risk of damaging the products: failure to observe and follow this instruction manual and the instruction manuals of products used in combination can result in injury to patients, users and third parties as well as damage to the product.Please read all relevant instruction manuals carefully and always follow the instructions given precisely.Check the functioning of the products used in combination.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 and risk of damaging the products: if applied parts are used outside of the field of vision there is a risk that tissue and accessories could be damaged unintentionally.Always hold the applied parts of the active electrode, laser and other instruments which transmit energy in a target-oriented manner in the field of vision during application.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.Based on the results of the investigation, the documented product quality, and the previous complaint history, no product-related defect can be identified.The cause of the reported injury cannot therefore be attributed to a defect in the item.This event is filed under internal 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: 21396032
• Report Number: 9610617-2025-00241
• Device Sequence Number: 7585876
• Product Code: GCJ
• UDI-Device Identifier: 04048551143285
• UDI-Public: 04048551143285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 33410ON
• Device Catalogue Number: 33410ON
• Device Lot Number: OP08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 03/23/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/25/2025; 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown