MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50

Model Number	UI500
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our us facility as documented in section d9, and will later be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The issue occurred during use in a veterinary procedure, and no adverse health effects were reported in any human.However, out of an abundance of caution, we will report this event, as we also market similar devices intended for human use.This event is filed under internal complaint id (b)(4).
Event or Problem Description
The following was reported: malfunction during procedure.It flashed a system failure alert and purged the insufflation in the middle of a procedure.We shut down the unit, even connected to a new co2 tank just in case there was an issue there.It restarted and seemed ok, but within a few minutes the same thing happened.Converted to open surgery and the patient is ok.Surgery was a vet surgery.No negative impact on the state of health for a human is reported.Since the device was used in a veterinary procedure we decided to voluntarily report this as a malfunction at least to the us fda, however we do not report it as a serious injury, since no human was affected and the medwatch reporting system is originally designated for human health impacts.

• Brand Name: ENDOFLATOR 50
• Common Device Name: 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 ; 4242188247
• MDR Report Key: 25418337
• Report Number: 9610617-2026-01220
• Device Sequence Number: 20355271
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 04048551326657
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: UI500
• Device Catalogue Number: UI500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/06/2026
• 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