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

Model Number 006889-901

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.Therefore, the cause of the reported device issue could not be conclusively determined at this time.Based on similar reported events, user handling and the operator¿s technique could not be ruled out as contributing factors to the reported event.The instruction manual provides several warning and caution statements in an effort to mitigate equipment damage and patient harm.¿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 forward towards the distal end of the applicator.Carefully inspect applicator tongs prior to use.Do not use if tongs are 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.¿ if the device is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a laparoscopic tubal ligation (btl) procedure, the band did not deploy properly and fell inside the patient.The device had to be retrieved with an unspecified grasper.A different device was used to successfully complete the procedure.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus on april 9, 2018.The evaluation was unable to confirm the reported device issue.The device was returned in a used condition with a guide stuck on the distal end of the application.When the guide was removed, the dilator and band were found inside the guide.The features of the device were measured and measurements were found within standard specifications.The tip of the applicator was inspected under 10x magnification and found to be free from nicks and scratches.The handle was actuated and the tongs moved in and out of the inner tube smoothly with no resistance.The position lever was also actuated and the tongs moved easily from position 1 and 2.In addition, the device was loaded with two ring bands for testing and both bands deployed properly in position 1 and position 2 as designed.As part of our investigation, a device history review (dhr) was performed and found no anomalies with the manufacturing of the reported device.

• 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: 7374263
• MDR Text Key: 103946203
• Report Number: 2951238-2018-00212
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• 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: MK612808
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1