MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI VACUUM ASSISTED DELIVERY SYSTEM; FOETEL VACUUM ASSISTED DELIVERY DEVICE

Model Number	VAC-6000MTE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Fetal Distress (1856); Pain (1994); Anxiety (2328); Distress (2329)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received from the reporter a supplemental report may be submitted.Complaints will continue to be monitored for trends.
Event or Problem Description
Translated from french using google translate: "description of the incident/ occurrence of the incident: during an instrumental delivery using a kiwi vacuum extractor due to failure to progress and fetal heart rate abnormalities, the device broke.The incident occurred 3 times with 3 new devices, leading to the medical decision to use suzor forceps.Immediate action: replacement of 3 vacuum extractors with new devices.Replacement of the device with suzor forceps.Immediate apparent consequences: for patients: for the mother: prolonged delivery with increased pain, stress with post-traumatic anxiety, and other potential risks.For the baby: fetal distress in a newborn already experiencing an abnormal heart rhythm, prolonged delivery time, with potential increased pain, probable post-traumatic stress.For healthcare professionals: insecurity, event management, stress, workload overload.For the facility: economic cost due to the need for additional equipment and other potential consequences on patient care.We would appreciate it if you could inform us whether this type of incident is recurring or isolated.Assured that we share this same commitment to improving the quality and safety of care, i remain, madam/sir, yours respectfully.".

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: FOETEL VACUUM ASSISTED DELIVERY DEVICE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4150 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4150 s; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 w 4150 s; murray, UT 84123 ; 9782776432
• MDR Report Key: 24579026
• Report Number: 1722684-2026-00009
• Device Sequence Number: 13069685
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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
• Device Model Number: VAC-6000MTE
• Device Lot Number: 251625
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown