MAUDE Adverse Event Report: PANPAC MEDICAL CORPORATION MANIPULATOR INJECTOR; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	UMI 4.5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device broke about 4 inches inside the patient.

• Brand Name: MANIPULATOR INJECTOR
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): PANPAC MEDICAL CORPORATION; 2051 junction ave; suite#128; san jose CA 95131
• MDR Report Key: 15629296
• Report Number: 15629296
• Device Sequence Number: 5911793
• Product Code: LKF
• UDI-Device Identifier: 04715309125199
• UDI-Public: (01)04715309125199
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/09/2022
• Report Date (Section F): 10/09/2022

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 Model Number: UMI 4.5
• Device Catalogue Number: LTL-1151
• Device Lot Number: A22042W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/09/2022