MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MULTIFUNCTIONAL VALVE, SIZE 11 MM

Model Number	30103M2
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It is reported that the pin is broken, and the valve fell off.There is no information that the event caused a harm or serious injury to patient, user or third.New information received on (b)(6) 2025 that this event happened during medical procedure.
Additional Manufacturer Narrative
This correction mdr is to make clear that device in question was returned to the manufacturer.This information is reflected in section d9 of the initial mdr submitted.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).Date of investigation: january 23, 2025.Result of investigation: the customer reports that "the pin on the cap of item 30103m2 broke, causing the cap to fall off".The pin on the cap was intact and the cap was properly attached to the item.It is unclear whether the customer reattached the cap before returning it.The pin is 11.11 mm long, while the drawing indicates a nominal length of 14.8 mm.A break could not be clearly determined on the basis of the visible characteristics, since no break point was recognizable.Despite the shorter length of the pin, the cap remained stable because it could be easily wedged.The spring had sufficient tension to hold the cap securely.The pin is well protected by the valve housing and can only be damaged by the application of excessive force, e.G., opening the cap beyond the normal opening angle.However, such a load would also have damaged the spring, which was not the case here.An analysis of the complaint data showed that this is the first incident of its kind in the last four years.Mechanical damage to the pen through improper use cannot be ruled out.A possible manufacturing defect, such as insufficient length testing of the pen, seems possible but could not be confirmed.Based on the results of the investigation and the lack of clear evidence of a specific cause of the defect, the defect cannot be clearly attributed to either a manufacturing process or a specific misuse.Based on the available information and examination results, it is not possible to clearly determine and identify the cause of the defect.

• Brand Name: MULTIFUNCTIONAL VALVE, SIZE 11 MM
• Common Device Name: MULTIFUNCTIONAL VALVE
• 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: 21140165
• Report Number: 9610617-2025-00023
• Device Sequence Number: 12641597
• Product Code: GCJ
• UDI-Device Identifier: 04048551117620
• UDI-Public: 04048551117620
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K940347
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: 30103M2
• Device Catalogue Number: 30103M2
• Device Lot Number: NM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 01/08/2024; 02/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/14/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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