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

Model Number	30103A1
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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 was reported that the cap from the valve has come loose.Patient had to be operated on again.
Additional Manufacturer Narrative
Correction in h11 internal karl storz complaint id (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The investigation of the product was completed on may 21, 2025.The visual inspection of the returned article showed that the sealing screw is missing.According to the available lot code the article was manufactured in april 2009.It is therefore 16 years old.Due to the age of the valve and the assumed number of reprocessing, the adhesive on the screw connection, for example, may have come loose.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: AUTOMATIC VALVE, 11 MM
• Common Device Name: AUTOMATIC VALVE, 11 MM
• 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: 21720345
• Report Number: 9610617-2025-00529
• Device Sequence Number: 9537091
• Product Code: GCJ
• UDI-Device Identifier: 04048551117217
• UDI-Public: 04048551117217
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 30103A1
• Device Catalogue Number: 30103A1
• Device Lot Number: DA
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 04/01/2025; 05/21/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 03/31/2025; 04/28/2025; 05/23/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown