MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/O TROCAR 8/PK

Model Number 006889-901

Device Problems Device Or Device Fragments Location Unknown (2590); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Therefore, the cause of the reported event could not be conclusively determined.However, based on similar reported events, the operator's technique could not be ruled out as a contributing factor to the reported event.The instruction manual provides several warning and caution statements in an effort to mitigate equipment damage and harm to the patient."verify that the disposable applicator is properly set for firing by checking the index trigger position as follows.When selecting a firing position, rotate index lever until a positive stop is felt.Extend the tongs and grasp the fallopian tube by moving the operating slide towards the distal end of the applicator.Carefully inspect applicator tongs prior to use.Do not use if tongs are out of alignment or 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.".

Event Description

Olympus received a medwatch report (mw5076770) on may 14th which states, "there was an unsuccessful attempt to deploy the falope ring.Upon removing the instrument, ring was no longer on the applicator.The intra-abdominal cavity, operating room table drapes and table were searched but the ring band could not be located." there was no adverse event reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the oem.A review of the device history records (dhr) for the concerned lot number was conducted and all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: FBK DUAL INC. W/O TROCAR 8/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7563035
• MDR Text Key: 110453867
• Report Number: 2951238-2018-00329
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• PMA/PMN Number: P870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Catalogue Number: 006889-901
• Device Lot Number: GM604228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1