MAUDE Adverse Event Report: GYNETECH PTY LTD COLPOTOMIZOR TUBE SYSTEM; CULDOSCOPE (AND ACCESSORIES)

Model Number CTS35-TV

Device Problem Leak/Splash (1354)

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

Event Date 11/09/2015

Event Type  malfunction  

Event Description

Balloon was leaking during pre-surgery testing.It happened in two different operations.

• Brand Name: COLPOTOMIZOR TUBE SYSTEM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYNETECH PTY LTD; 122 balmain street; richmond, victoria 3121 ; AS 3121
• MDR Report Key: 5972002
• MDR Text Key: 55427733
• Report Number: 3010570913-2015-00001
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016

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
• Device Operator: No Information
• Device Model Number: CTS35-TV
• Device Lot Number: 3517315
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/12/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other