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

Model Number 006889-901

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The falope-ring band kit was received at the service center for evaluation of the reported issue "not deploying correctly/misfire".The device is currently being evaluated at the original equipment manufacturer for the root cause of the reported incident.Upon completion of the investigation, a supplemental report will be submitted to the agency.Udi# (b)(4).

Event Description

The service center received a report of a disposable falope-ring band kit (model 006889-901), lot number mk735611, that malfunctioned during a procedure.The falope-ring band kit was inspected prior to the procedure and no anomalies were observed.It was reported a physician used the falope-ring band during a therapeutic hysteroscopic occlusion of fallopian tubes, and the device did not deploy correctly/misfired.The physician opened and used a second falope-ring band kit to complete the procedure.It was reported there was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and device history record (dhr) review.The customer returned a 006889-901 falope-ring band applicator.The device was returned with the original tray and tyvek lid; the lot number was confirmed to be mk735611.One dilator, one applicator and no ring-bands were returned with the shipment.The device was evaluated for the reported problem of "did not deploy during the procedure." two bands were loaded, the device was tested and functioned as intended.No physical anomalies were noted.The dhr for this product has 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 definitive root cause could not be determined as the device functioned as designed.The reported failure may be the result of mishandling or misuse.The device ifu warns, "improper use of the applicator may result in a falope-ring band being inadvertently discharged into the peritoneal cavity or entrapping the fallopian tube within the applicator forceps tongs.Refer to sections 3.4 and 3.5 for the proper use of the applicator and the recommended method to release an entrapped fallopian tube.".

• Brand Name: FBK DUAL INC. W/O TROCAR 8/PK
• Type of Device: DISPOSABLE FALOPE-RING BAND
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9793835
• MDR Text Key: 222556484
• Report Number: 2951238-2020-00354
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00821925032989
• UDI-Public: (01)00821925032989(17)230228
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 006889-901
• Device Lot Number: MK735611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1