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

Model Number	VAC-6000C
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
In the customers words: "the kiwi was used during a c-section.After delivery a small white piece of plastic was found in abdominal cavity while closing the uterus.We were unsure of the origin of the plastic.After patient left the or we discovered that the piece came from the handle of the kiwi.I called the company to report incident.It was then that we found that there are two pieces that should have been retrieved.The silicone disc that is under the piece of plastic was not seen.The kiwi that was used was removed from the trash and was found to be missing both pieces.".
Additional Manufacturer Narrative
The complaint is not confirmed.No product evaluation could be performed because the device wasn't returned and no photos were provided by the customer.Per risk-0027 rev.03, the complaint may be associated with the following potential failure mode: harm 2: delayed procedure with fetal distress.Severity: 4.Potential causes: inadequate device design, design requirements not met, inadequate design verification.Probability of occurrence: 1.Risk is considered "monitor".No root cause can be determined because the complaint was not confirmed.

• Brand Name: KIWI VACUUM ASSISTED DELIVERY
• Common Device Name: FETAL VACUMM 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: kellie stefaniak ; 747 w 4170 s; murray, UT 84123 ; 8012606079
• MDR Report Key: 15075642
• Report Number: 1722684-2022-00006
• Device Sequence Number: 4784801
• Product Code: HDB
• UDI-Device Identifier: 00814247020628
• UDI-Public: 00814247020628
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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 Expiration Date: 09/23/2023
• Device Model Number: VAC-6000C
• Device Lot Number: 214584
• 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: 06/27/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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