MAUDE Adverse Event Report: HUMI MANIPULATOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	AMI-1151
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Uterine manipulator was placed at beginning of laparoscopic ovarian cystectomy then at the end of the procedure when manipulator was removed it was broken.No retained pieces.Patient had no injury.(b)(6).

• Brand Name: HUMI MANIPULATOR
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• MDR Report Key: 18686259
• Report Number: MW5151358
• Device Sequence Number: 8274467
• Product Code: LKF
• UDI-Device Identifier: 04715309125199
• UDI-Public: (01)04715309125199
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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 Expiration Date: 10/31/2025
• Device Model Number: AMI-1151
• Device Lot Number: A221114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White