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 Code	Insufficient Information (4580)
Date of Event	02/09/2026
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: "this is a follow-up to our telephone conversation yesterday with (b)(6) regarding a medical device vigilance report concerning kiwi omnicup traction force devices at the (b)(6) hospital.The device in question is the kiwi omnicup traction force vac-6000mte, batch number 251652.We have observed that the traction indicator cartridge detaches from the vacuum extractor handle during use, both during vaginal deliveries and cesarean sections.This malfunction has resulted in injuries to newborns, documented in at least four separate incidents, reported by at least two obstetricians at our facility.To date, a total of 75 devices from this batch have been identified and immediately placed in quarantine.Furthermore, obstetricians are now refusing to use this device and are turning to alternative solutions, such as spatulas or forceps, to ensure patient safety.We request the immediate recall of this batch and its replacement with compliant devices to ensure continuity of care under optimal safety conditions.Thank you in advance for keeping us informed of any developments in this matter.Since the change in medical devices, the insertion of kiwi devices by gynecologists has become very risky.The kiwi devices break, forcing us to use 3-4 per patient, with a risk of injury to newborns.".

• 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: 24580751
• Report Number: 1722684-2026-00003
• Device Sequence Number: 13050894
• 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: Administrator/Supervisor
• 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
• Operator of Device: Health Professional
• Device Model Number: VAC-6000MTE
• Device Lot Number: 251652
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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