MAUDE Adverse Event Report: GYRUS ACMI, INC FALOPE RING BAND KIT; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number 006889-901

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.However, as a preventive measure, the instruction manual for use gives several warnings in an effort to mitigate 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.¿.

Event Description

Olympus was informed that during a laparoscopic tubal ligation procedure, the patient¿s second fallopian tube became damaged while attempting to apply the ring band.The user facility reported the rubber band on the tip of the applicator did not come off during the procedure as it should have.The wires crossed and it failed to deploy.As a result, there was moderate bleeding observed the patient's tube.To stop the bleeding, the user facility reported that part of the patient¿s tube had to be removed and was sealed with a ligasure device.The intended procedure was completed with a similar device.The procedure was prolonged by about 20 minutes.In addition, there was no device component that fell into the patient and the patient did not require a longer stay or an additional procedure.

Manufacturer Narrative

A review of the device history records indicated that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.To date, no device has been returned to the manufacturer for evaluation, however, the potential cause of the reported event was likely a result of user mishandling or poor technique.The device instruction for use (ifu) manual, man-8115, illustrates proper usage technique.If the referenced device is returned at a later date, this report will be supplemented accordingly.

• Brand Name: FALOPE RING BAND KIT
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8580526
• MDR Text Key: 144102676
• Report Number: 2951238-2019-00805
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Lot Number: KR836388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention