MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/TROCAR 8/PK

Model Number 005280-901

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center followed up with the user facility and was informed the seal damage occurred at the beginning of the case.The user facility reported no pieces are missing from the rubber seal.No unexpected bleeding was observed.The kit was inspected prior to the procedure with no anomalies noted.There was no longer stay or additional procedures needed.The intended procedure was completed; however, was prolonged by about 10 minutes.There was no patient injury reported.

Event Description

The service center received medwatch report that states in (b)(6) of 2019 during a laparoscopic tubal ligation, while trying to remove the obturator from the trocar sleeve, it became stuck and could not be removed.The surgeon tried 3-4 times pulling obturator out a little, rotating it, and finally he was able to remove it.However, it did fracture the rubber seal at the end of the trocar.He searched extensively inside the patient with scope/camera for any rubber pieces, but did not find any inside the patient.He does not believe anything was left in the patient.The surgical case was continued with the trocar sleeve in place but he had to place his finger over the end with each instrument exchange to maintain the pneumoperitoneum.

Manufacturer Narrative

This supplemental report is being submitted to correct the previously reported aware date from aug 19, 2019 to aug 15, 2019.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information.Please the updates in sections: g4, g7, h2, h3, h6 and h10.The device-level (005280-901 kr837389) 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 total of 30 units were produced under this lot number with no associated deviations relating to the reported failure.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: FBK DUAL INC. W/TROCAR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8683473
• MDR Text Key: 147648406
• Report Number: 2951238-2019-00924
• 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,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

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: KR837389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 10/02/2019
• Supplement Dates FDA Received: 09/18/2019; 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 51