MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/TROCAR 8/PK; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSIION

Model Number 005280-901

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned for evaluation.The investigation is in progress.

Event Description

Olympus received a complaint from a user facility stating that during a procedure, their device locked up.No patient harm was reported.

Event Description

Additional information was provided that stated that the patient had a tubal ligation procedure.During the procedure, the falope ring was unable to be loaded on the deployer part of the ring set.The device was removed and a new device was used to complete the procedure without any issues.

Manufacturer Narrative

This report has been updated in sections: d 10, g4, g7, h2, h3, h6 and h10.The device was returned for evaluation in the original tray.The lot number was confirmed to be mk711087.Two dilators, two applicators, the 5mm reducer and the trocar knife were included in the shipment.The applicator was returned in firing position two.Functional testing was performed with the returned device, it functioned as designed with no abnormalities noted, the user's experience could not be replicated.The device history record (dhr) for this product was reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based upon a review of production documentation and evaluation of the returned device there is no evidence to suggest manufacturing contributed to the reported failure.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSIION
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9960132
• MDR Text Key: 200016073
• Report Number: 2951238-2020-00418
• 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,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 005280-901
• Device Lot Number: MK711087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 05/07/2020
• Supplement Dates FDA Received: 04/17/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 106