MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI VACUUM ASSISTED DELIVERY SYSTEM; VACUUM EXTRACTOR

Model Number	UM700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint is not confirmed.No product evaluation can be performed because the device was not returned and no photos were provided by the customer.A dhr review could not be performed because the lot number is unknown.Risk assessment: per fmea risk-0006 rev.02, the complaint may be associated with the following potential.Failure mode: potential failure mode: failure to secure spacer appropriately.Potential effect: spacer is retained in the vagina.Harm: foreign body in patient.Severity: 4.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor." root cause analysis: no root cause can be determined because the complaint is not confirmed.
Event or Problem Description
In the customer words: " spacer came off during the surgery, but doctors were not aware.Spacer was found after finishing the surgery and picked out three days later." no injuries reported.

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT 84123 ; 8012606086
• MDR Report Key: 16462778
• Report Number: 1722684-2023-00002
• Device Sequence Number: 2393820
• Product Code: HDB
• UDI-Device Identifier: 00814247020017
• UDI-Public: 00814247020017
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K940681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: UM700
• 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: 02/20/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown