MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VALVE SEAL

Model Number	021199-10
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Output Problem (3005); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the valves of the trocars broke during their first use the handle presented excessive resistance when opening/closing and when rotating the knob, they were in the process of performing surgery on a newborn patient when the products mention failed.As reported patient is in the usual condition expected after surgery of this type (there is no worsened condition due to the equipment failure).During the procedure, the valves of the trocars broke during their first use, approximately halfway through the surgery.As a consequence, the surgical team repeatedly lost pneumothorax, which caused respiratory complications and jeopardised the continuation of the procedure.According to the hospital, the instruments inserted were compatible and were handled with care.It was reported that the monopolar cable supplied in the same order did not function.The medical team confirmed that the issue was caused by the cable itself, as when replaced with another storz cable available at the hospital, the system worked correctly.Issues were identified in the handle, which was being used for the second time.The clinicians reported that the handle presented excessive resistance when opening/closing and when rotating the knob, compared with what is normally expected for this type of instrument.Procedure completed with 1.5 hours delay without any harm or injury to patient reported.No negative impact in state of health reported.
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).

• Brand Name: VALVE SEAL
• Common Device Name: VALVE SEAL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24853507
• Report Number: 2020550-2026-00746
• Device Sequence Number: 21150025
• Product Code: GCJ
• UDI-Device Identifier: 04048551400227
• UDI-Public: 04048551400227
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/11/2026
• Report Date (Section F): 04/11/2026

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: 021199-10
• Device Catalogue Number: 021199-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26002M- SK01.; 30114G5-ZM01.; 30114G5-ZM01.; 30114NS-XL01.; 30114NS-XL01.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown