MAUDE Adverse Event Report: COOPERSURGICAL, INC. H/S ELLIPTOSPHERE PROCEDURE TRAY; CANNULA, MANIPULATOR/INJECTOR

Model Number 61-4205

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

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

Event Date 12/09/2014

Event Type  malfunction  

Event Description

We had two failures of the balloon for the cervical catheter in our hysterosalpingogram elliptosphere procedure trays from lot 173395, ref 61-4205.With the first procedure, the balloon worked properly when tested prior to insertion.However, the balloon failed after the catheter was inserted necessitating recatheterization of the patient (an uncomfortable procedure).The patient was informed of the issue when it occurred.In the second case, the balloon would not hold air when the doctor tested it prior to the procedure.I have contacted quality, patient safety, regulatory compliance, risk management, as well as the vendor for the item.We have not had additional issues at this time.No other issues have come up at this time.Still waiting to hear back from cooper surgical.

Manufacturer Narrative

(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.A final report will be filed after customer follow up and investigation is complete.

• Brand Name: H/S ELLIPTOSPHERE PROCEDURE TRAY
• Type of Device: CANNULA, MANIPULATOR/INJECTOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4495432
• MDR Text Key: 5499704
• Report Number: 1216677-2015-00003
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2014,12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2016
• Device Model Number: 61-4205
• Device Catalogue Number: 61-4205
• Device Lot Number: 173395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2014
• Event Location: Other
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other