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

Model Number UM-TVPRO-37

Device Problems Bent (1059); Break (1069); Material Perforation (2205); Device Dislodged or Dislocated (2923)

Patient Problem Uterine Perforation (2121)

Event Type  malfunction  

Manufacturer Narrative

Event Description

Manipulator pro shaft bent during surgery making it difficult to manipulate the uterus.Metal distal tip of balloon broke through balloon causing it to deflate and then perforate through the uterus.Surgeon was using manipulator pro during a tlh procedure and the shaft on the manipulator bent limiting manipulation of the uterus and the distal metal tip of the manipulator pro somehow became dislodged from where it connects to the balloon and perforated through the balloon and uterus.

• Brand Name: MANIPULATOR PRO 37MM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): GYNETECH PTY LTD; 122 balmain street; richmond, victoria 3121 ; AS 3121
• Manufacturer Contact: henry fong ; 122 balmain street; richmond, victoria 3121 ; AS 3121 ; 3 9413555
• MDR Report Key: 5969077
• MDR Text Key: 55692335
• Report Number: 3008254127-2016-00003
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• 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-37-10415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other