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

Model Number	26432020-1
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2025, in the operating room, the doctor used the insufflatorto expand the surgical field and found that the insufflator failed to supply gas, affecting theoperation.The technical staff was immediately contacted for inspection, and the equipment was replaced.After replacement, the operation proceeded normally.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction in section d and g4 product information.The device is not expected to be returned should relevant additional information become available, a supplemental medwatch report will be submitted.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: 24835205
• Report Number: 9610617-2026-00795
• Device Sequence Number: 9187785
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 04048551069264
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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