MAUDE Adverse Event Report: FEMCARE LTD. FISHIE CLIP SYSTEM; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number M2174 MINILAP

Device Problem Mechanical Problem (1384)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/09/2020

Event Type  Injury  

Event Description

Patient was in surgery for a bilateral tubal ligation procedure using the filshie clips.The filshie clip device was used on the right-side fallopian tube.The attempt to set the filshie clamp failed resulting in a bleed and hematoma from the right fallopian tube.Due to the active bleeding a laparoscopic right salpingectomy had to be completed.Instrument preparation and/or user technique could not have contributed to the outcome.

• Brand Name: FISHIE CLIP SYSTEM
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 11055967
• MDR Text Key: 223457881
• Report Number: MW5098485
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2174 MINILAP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Required Intervention
• Patient Age: 34 YR