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

Model Number 006889-901

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

The referenced device (006889-901) was not returned to olympus for evaluation.Therefore the cause of the reported event could not be determined.However, based on similar reported complaints the most probable 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.¿extend the tongs and grasp the fallopian tube by moving the operating slide forward towards the distal end of the applicator (a).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 (see section 3.3).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 additional information becomes available or if the device is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that the device misfired during an unspecified procedure.No injury was reported.Limited information was reported.Olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing but with no result.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.A visual inspection of the device observed no scratches or burrs on the distal tip of the device.The handle was actuated and the tongs moved in and out of the inner tube smoothly.The feature dimensions met all specifications.The device was loaded with the ring bands for testing and both bands deployed appropriately.Based on the device evaluation results, the cause of the reported event could not be confirmed as there was no damage to the applicator and the device functioned as designed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.Olympus was informed that the device misfired a band upon deployment during a laparoscopic tubal ligation.As a result, there was no bleeding to the patient and the patient did not require additional stay or procedures.The procedure was delayed 2-3 minutes as a new band was loaded and the procedure was completed.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6777878
• MDR Text Key: 82781540
• Report Number: 2951238-2017-00518
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 006889-901
• Device Lot Number: GM604214
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1