MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/O TROCAR 8/PK; FALOPE-RING BAND APPLICATOR

Model Number 006889-901

Device Problems Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

However, if additional information becomes available or if the device is returned for evaluation, this report will be supplemented accordingly.

Event Description

Olympus was informed by the user facility that during a tubal ligation procedure, the falope ring was reported to have caused tubal lacerations.

Manufacturer Narrative

This report is being submitted to provide additional information from the user facility.On may 10, 2018, the user facility further reported that during the middle of the procedure the patient¿s fallopian tube tore when the fallopian ring applicator was triggered on the second fallopian tube, however, the user facility stated no additional procedure was performed for the injury as a second fallope ring applicator was opened and used to finish the procedure.The patient was discharged and is doing fine.The procedure was delayed 10 minutes.The device was inspected prior to the procedure with non anomalies observed.Olympus received a copy of medwatch report (mw5076662) on may 14, 2018.The user facility reported a malfunction and no adverse event which is conflicting information to the reported event.No device has been returned to olympus for evaluation.Therefore, the exact cause of the reported event could not be determined; however, the most likely cause could be attributed to the operator¿s technique.The instruction manual for use gives several warnings in an effort to prevent fallopian tube damage which states, ¿extend the tongs and grasp the fallopian tube by moving the operating slide forward toward the distal end of the applicator.Grasp with the inferior tong positioned on the bottom of the fallopian tube to avoid injury to the tube.Carefully inspect applicator tongs prior to use.Do not use tongs if out of alignment or are damaged, as patient injury can result.Always grasp the fallopian tube with the shorter inferior tong positioned on the bottom to avoid injury to the tube.¿ additionally, a review of the device history records (dhr) was conducted for the concerned lot number which showed the device was manufactured according to valid instructions and met all specifications.

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: FALOPE-RING BAND APPLICATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7445558
• MDR Text Key: 106008486
• Report Number: 2951238-2018-00255
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• PMA/PMN Number: PP870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 006889-901
• Device Catalogue Number: 006889-901
• Device Lot Number: MK612808
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other