MAUDE Adverse Event Report: BAYER HEALTHCARE LLC TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Sticking (1597); Material Protrusion/Extrusion (2979)

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

Event Date 11/30/2016

Event Type  malfunction  

Event Description

First device worked fine, second device the handpiece became stuck and could not be used.Third device, too many coils were exposed before deploying.Fourth device worked fine.Two devices were removed from patient, examined and confirmed devices were complete.Manufacturer response for essure, bayer-essure permanent birth control (per site reporter): rep in the operating room during procedure.No other response from mfr.

• Brand Name: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; manal morcos; 100 bayer blvd.; whippany NJ 07981
• MDR Report Key: 6249081
• MDR Text Key: 64749488
• Report Number: 6249081
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2016,12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ESS305
• Device Lot Number: C35240
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2016
• Event Location: Other
• Date Report to Manufacturer: 12/29/2016
• 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: 28 YR