MAUDE Adverse Event Report: GYRUS ACMI INC. DISPOSABLE FALOPE-RING BAND APPLICATOR KIT; TUBAL OCCLUSION DEVICE

Model Number 005280-901

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that a package was found open when attempting to use the device.This incident did not occur during a procedure.There was no patient involvement.The device was not used on a patient.No patient injury was reported.No further information was provided.

• Brand Name: DISPOSABLE FALOPE-RING BAND APPLICATOR KIT
• Type of Device: TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5147712
• MDR Text Key: 28141849
• Report Number: 2951238-2015-00490
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 005280-901
• Device Catalogue Number: 005280-901
• Device Lot Number: MK541811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0419-2015
• Patient Sequence Number: 1