MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/TROCAR 8/PK; FALOPE BAND APPLICATOR KIT

Model Number 005280-901

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned and evaluated for the reported, "trocar was in the patient in its sleeve and was difficult to remove." the device was returned in the original tray with all the accessories.A physical inspection noted that the inner self-seal was damaged inside the cannula.A piece of the seal was stuck to the trocar knife.The cap was removed from the cannula and the insert seal was confirmed to be in place and free from damage and therefore was not contributing to the reported phenomenon.The included reducer was in good condition and free from damage.In addition it was the stopcock was broken off the cannula.The outer diameter of the trocar knife was within specification.The inner diameter of the cannula was also within specification.Upon further inspection of the self-seal it was noted that fragments of the seal were missing.The suspected missing fragments were not returned for evaluation.The most probable cause of the damage to the self-seal may occur if the trocar knife is not inserted concentric to the trocar sleeve.The end of the knife is sharp and may damage the inner seal if not properly inserted.A dhr review for the concerned lot indicated that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on the investigation, the most probable cause of the reported event can be attributed to the operator's technique.

Event Description

The manufacturer was informed that at the beginning of a therapeutic bilateral tubal ligation procedure, the surgeon had a difficult time removing the trocar from the cannula.During the process of trying to remove the trocar forcefully, the stopcock on the trocar broke off.There was no tissue trauma or unexpected bleeding to the patient reported.No device fragments fell into the patient.The procedure was completed using the same equipment from the kit as the small white ring holder was used to plug the cannula and maintain pressure in the abdominal cavity to complete the procedure.The surgical time was extended by approximately less than 30 minutes due to the complication with the trocar.The patient did not require any additional treatment or a longer stay as the patient was discharged per normal standards.The whole kit was inspected prior to use and no anomalies were noted.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: FALOPE BAND APPLICATOR KIT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8998327
• MDR Text Key: 158635221
• Report Number: 2951238-2019-01113
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 0082192500124
• UDI-Public: (01)0082192500124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2019

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 Expiration Date: 12/13/2023
• Device Model Number: 005280-901
• Device Lot Number: KR837389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1