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

Model Number	005280-901
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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).
Additional 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
• Common Device Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11266635
• Report Number: 3011050570-2021-00041
• Device Sequence Number: 19692873
• Product Code: KNH
• UDI-Device Identifier: 00821925032996
• UDI-Public: 00821925032996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P870076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 05/20/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/15/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 74