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 Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a laparoscopic tubal ligation using a fbk dual with trocar, the applicator became stuck on the fallopian tube of the patient.The physician had to make a small incision to introduce an additional port for passage of graspers to remove the entrapped device from the fallopian tube.No additional consequences to the patient were reported.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings and corrected data.Corrected information is reported in h6 (type of investigation): the device was returned for physical evaluation.Physical evaluation of the complaint device shows: olympus performed a visual inspection on the as is received condition of the device; noted that the device was returned in a clear plastic holder and came along with accessories.The device was returned with two guides, a trocar, a cannula and a reducer cap.The two dilators with pre-loaded bands were not returned for evaluation.The applicator was examined and olympus was unable to identify any physical damage or cracks in the thumb ring and lever arm portion.One of the two guides appear to have residue on the guide, which is consistent with usage.The reducer cap also has minor residue however the cannula and trocar have no indications of damage or residue.Olympus manipulated the applicator by pulling the thumb ring to extend the tongs from the distal end.The distal end was observed under a microscope and olympus verified that the was dried foreign material which is also consistent with usage.The tongs located near the distal end appears to have no signs of deformities or excessive bends.Olympus manipulated the thumb ring on the applicator to extend and retract the tongs at the distal end several times.Olympus verified that there were no restrictions or issues with the movement of the tongs through the inner tube of the applicator when the thumb ring was manipulated.Olympus is unable to perform a functional test as the dilators with the pre-loaded bands were not returned.The device history record (dhr) for the complaint device.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: "improper use of the applicator may result in a falope-ring band being inadvertently discharged into the peritoneal cavity or entrapping the fallopian tube within the applicator forceps tongs.Refer to sections 3.4 and 3.5 for the proper use of the applicator and the recommended method to release an entrapped fallopian tube".Conclusion: the observed failure is a known phenomenon and is produced as a result of error in operating the device.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: 11568353
• Report Number: 3003790304-2021-00058
• Device Sequence Number: 4139245
• Product Code: KNH
• UDI-Device Identifier: 00821925032996
• UDI-Public: 00821925032996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 005280-901
• Device Lot Number: KR831391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention