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

Model Number 006889-901

Device Problem Mechanical Problem (1384)

Patient Problem Tissue Damage (2104)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The cause of the reported failure cannot be determined.The most likely cause of the damage can be attributed to inadvertent handling of the device.The instruction manual contains warning statements in an effort to prevent possible damage."the falope-ring band may be damaged and/or break during loading with the use of damaged or reused loading devices.Using standard sterile technique, load the falope-ring band as follows (do not load the bands more than 30 minutes prior to placement).Always grasp the fallopian tube with the shorter inferior tong positioned on the bottom to avoid injury to the tube.".

Event Description

Olympus was informed that during a bilateral tubal ligation procedure, the device wouldn't deploy the fallopian ring.In an attempt to release the fallopian ring and cut the fallopian tube, the fallopian tube was severed.The device was removed and a non-olympus device was used to complete the procedure.No additional bleeding was observed and no other surgical intervention was required.

Manufacturer Narrative

The device was returned for evaluation.The report of the device not deploying the fallopian ring could not be confirmed.Visual inspection found there was one ring band still on the tip of the applicator.Two bands were loaded and deployed as expected.There were no significant abnormalities observed during device functionality testing.No sharp edges or nicks were present.The handle was also disassembled to reveal the trigger tube in good condition with only a slight wear mark on one side.

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: FALOPE-RING BAND APPLICATION
• Manufacturer (Section D): GYRUS AMCI, INC.; 136 turnpike road; southborough 01772
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5610390
• MDR Text Key: 43714242
• Report Number: 2951238-2016-00386
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Catalogue Number: 006889-901
• Device Lot Number: MK984367
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other