MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/TROCAR 8/PK; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number 005280-901

Device Problems Labelling, Instructions for Use or Training Problem (1318); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation (as it is implanted in a patient).To this date, there has been no adverse effects to the patient as a result of this occurrence.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported a fallope ring band was implanted in a patient four days past it's labeled expiration date.There was no reported injury or infection due to this occurrence.

Event Description

Additional information provided by the customer 17feb2021: the procedure being performed was a laparoscopic bilateral tubal ligation with fallope rings.The patient has reported no side effects as of (b)(6) 2021, denying any pain, headaches, nausea/vomiting or abdominal pain.The device was not inspected prior to use.

Manufacturer Narrative

This report is being updated to provide additional information reported by the customer.New information is reported in: a2, a4, b5, b7, g4 (combination product), and h6 (component code, and health effects/impact code).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the event was caused by the user error.Devices should not be used past expiration date.Olympus will continue to monitor the field performance of this device.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11266635
• MDR Text Key: 245097405
• Report Number: 3011050570-2021-00041
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00821925032996
• UDI-Public: 00821925032996
• Combination Product (y/n): N
• PMA/PMN Number: P870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: 005280-901
• Device Lot Number: MK988004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 74