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 Laceration(s) (1946)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user facility and will not be returned to olympus for evaluation.The cause of the reported event could not be determined; however, the most likely 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 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

The service center was informed that during a tubal ligation procedure, the applicator deployed two bands, although it to set to deploy one.The doctor went to deploy the band and grasp the patient¿s fallopian tube with the metal tongs causing a laceration.The user facility reported that this phenomenon has been noted over the past several months.The doctor had to use two kits, and the cautery unit to cauterize the fallopian tube and treat the bleeding.The procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to report additional information.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 (b)(4) units were produced under this lot number with no associated 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 8/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9304569
• MDR Text Key: 167389522
• Report Number: 2951238-2019-01180
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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: KR848761
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention