MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSUFFLATION TUBING SET, ENDOFLATOR 50

Model Number	031210-10
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product is getting too hot.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: as no product has been returned, a final determination of the root cause is not possible.Most likely, the gas flow has been reduced or blocked at least for a while to create overheating.The device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing or design related failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INSUFFLATION TUBING SET, ENDOFLATOR 50
• Common Device Name: INSUFFLATION TUBING SET, ENDOFLATOR 50
• 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: 21381648
• Report Number: 9610617-2025-00202
• Device Sequence Number: 15602064
• Product Code: NKC
• UDI-Device Identifier: 04048438005330
• UDI-Public: 04048438005330
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 031210-10
• Device Catalogue Number: 031210-10
• Device Lot Number: P0715-2412
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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