MAUDE Adverse Event Report: STRYKER INSTRUMENTS; CANNULA

Catalog Number 250-080-138

Device Problem Fluid/Blood Leak (1250)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

Surgeon placed the uterine manipulator cone in the vaginal vault.At the end of the surgery the surgeon stated they removed the device and placed it on the back table.The cone portion was not attached and it went unnoticed by the surgeon and the surgical team.The patient returned to the emergecny department the following day after experiencing a gush of fluid leaking down their leg and felt a 'popping' sensation and felt something hanging out of their vagina.The device was removed by the emergency department physician.

• Type of Device: CANNULA
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 4278718
• MDR Text Key: 5294541
• Report Number: 4278718
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 250-080-138
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATEINT WAS IN SURGERY AT THE TIME.
• Patient Weight: 59