MAUDE Adverse Event Report: BIOTEQUE TAIWAN LTD. BIOTEQUE TAIWAN LTD.; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	UMI4.5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient s/p [status post] lap ovarian cystectomy and oophorectomy.Distal portion of zumi manipulator broke off inside vagina.Patient denies complications related to same.

• Brand Name: BIOTEQUE TAIWAN LTD.
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): BIOTEQUE TAIWAN LTD.; 1302 exchange drive, suite 150; richardson TX 75081
• MDR Report Key: 23062841
• Report Number: 23062841
• Device Sequence Number: 9671046
• Product Code: LKF
• UDI-Device Identifier: 04719894432878
• UDI-Public: (01)04719894432878
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/06/2025
• Report Date (Section F): 08/06/2025

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: UMI4.5
• Device Lot Number: A240607
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 08/06/2025