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 Injury (2348)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

The 006889-901 disposable dual incision falope-ring was returned for evaluation.A visual inspection was performed on the received device and found no issues with the device.The applicator was inspected and did not see any external damage.The device lever was manipulated and the movement was consistent and normal.The lever arm was observed and the movement was consistent and smooth.The thumb ring was checked and the rotation of the ring was normal.Based on the evaluation findings, the user¿s complaint could not be confirm as the device operates normal.According to the ifu it states ¿do not remove the loading pin before both bands are loaded.Be sure the index lever is in the first firing position (see section 3.5, pg.22).Lubricate the falope-ring band with sterile water to facilitate loading.A slight resistance is felt just prior to full retraction of the tongs.Additional retraction pressure will automatically release the band onto the fallopian tube.¿.

Event Description

The service center was informed that during a bilateral laparoscopic tubal procedure, the first band deployed fine; however, when the second band was fired the tongs crossed and ripped the fallopian tube slightly.There was unexpected moderate bleeding reported.The surgeon then decided to use a ligasure device to stop the bleeding and remove both tubes.No device fragment fell into the patient.No longer stay or additional procedures needed for the patient.The case was delayed 5 minutes.The intended procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information from the original equipment manufacturer (oem).The dhrs for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 30 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: FBK DUAL INC. W/O TROCAR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9290369
• MDR Text Key: 165414285
• Report Number: 2951238-2019-01176
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 006889-901
• Device Lot Number: KR857512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention