MAUDE Adverse Event Report: ZINNANTI UTERINE MANIPULATOR; CANNULA, MANIPULATOR, INJECTOR, UTERINE

Model Number 2372

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

Pt was seen for a post operative visit (b)(6) 2017 and on pelvic exam a piece of the uterine manipulator was removed from her vagina.

• Brand Name: ZINNANTI UTERINE MANIPULATOR
• Type of Device: CANNULA, MANIPULATOR, INJECTOR, UTERINE
• MDR Report Key: 6809685
• MDR Text Key: 83466574
• Report Number: MW5071731
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2017

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: Health Professional
• Device Model Number: 2372
• Device Catalogue Number: TM1151-MPM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR