MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR SCB

Model Number	26432020-1
Medical Device Problem Codes	Improper Flow or Infusion (2954); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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 was reported that the patient underwent an elective thoracoscopic.A storz insufflator was used at the start of the surgery, at which point it was found that the pneumoperitoneum could not be maintained in the patient, resulting in a poor surgical field of view.After ruling out insufficient co2 supply from the central gas supply system, the insufflator was determined to malfunction.The insufflator was replaced, after which it functioned normally; the entire process took approximately 20 minutes, and the surgery was successfully completed in the end.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for inspection.Therefore, no technical inspection could be carried out and the error description provided by the customer, "insufflation abnormality", could not be confirmed.However, according to the reported issue, the cause can be attributed to a random electronic component defect due to wear.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: THERMOFLATOR SCB
• Common Device Name: THERMOFLATOR SCB
• 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: 24338597
• Report Number: 9610617-2026-00309
• Device Sequence Number: 9790695
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 04048551069264
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K955073
• 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
• Report Date (Section B): 05/13/2026

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: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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
• Patient Sex: Unknown