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

Model Number ESS305

Device Problems Material Fragmentation (1261); Device Inoperable (1663)

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

Event Date 12/01/2016

Event Type  malfunction  

Event Description

The surgeon inserted an essure device into patient, when the essure device malfunctioned per surgeon.Surgeon decided to do a laparoscopic bilateral salpingectomy, during which pieces of the coil from the essure device were retrieved by surgeon.Essure packaging and the pieces of coil given to the ambulatory surgical center operating room acm.Essure device reference number = ess305, lot number = c59253 expiration date= 05-2017.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 6236255
• MDR Text Key: 64274576
• Report Number: 6236255
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2016

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: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: ESS305
• Device Catalogue Number: ESS305
• Device Lot Number: C59253
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR