MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Foreign Body In Patient (2687)

Event Date 05/01/2015

Event Type  Injury  

Event Description

(b)(4) abdominal pain.This was the month of my first actual appointment.I went through ovarian cysts, which i had to take supplemental hormones to control.When the pain did not subside i had a diagnostic laparoscopy done on (b)(6) 2016 and found both clips had fallen off and were laying in my pelvis.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6034467
• MDR Text Key: 57656367
• Report Number: MW5065452
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 30.000 YR