MAUDE Adverse Event Report: SURGI SUPPLIES INTERNATIONAL PTY LTD MANIPULATOR PRO 37MM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number UM-TVPRO-37

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

After the hysterectomy, when removing uterus from patient, the manipulator pro was taken out with perforation in the balloon.The "top cap" of the balloon had loosened from the metal top part of the manipulator.

• Brand Name: MANIPULATOR PRO 37MM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): SURGI SUPPLIES INTERNATIONAL PTY LTD; unit 3/29 macquarie drive; richmond, thomastown 3047 ; AS 3047
• Manufacturer (Section G): SURGI SUPPLIES INTERNATIONAL PTY LTD; unit 3/29 macquarie drive; thomastown, victoria 3074 ; AS 3074
• Manufacturer Contact: shruthi challa ; unit 3/29 macquarie drive; thomastown, victoria 3074 ; AS 3074 ; 3 9466 28
• MDR Report Key: 6111442
• MDR Text Key: 60687606
• Report Number: 3008254127-2016-00006
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UM-TVPRO-37
• Device Lot Number: ORMP-37-11116
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other