MAUDE Adverse Event Report: GYRUS ACMI, INC FBK DUAL INC. W/TROCAR 8/PK; FALLOPIAN TUBE CLIP/BAND

Model Number 005280-901

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2022

Event Type  Injury  

Event Description

The 005280-901 falope ring applicator is not deploying the band properly.The customer has lost bands inside the patient and will ne ed to retrieve them.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.Sections b5 and g2 were corrected with information that was inadvertently left out of the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the band deployment issue could not be determined.It is possible that the phenomenon occurred due to improper usage of the ring applicator, or inadvertent use.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿improper use of the applicator may result in falope-ring bands being inadvertently discharged into the peritoneal cavity or entrapping the fallopian tube within the applicator forceps tongs." three attempts were performed to obtain additional information, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

Event Description

The bands were found and were able to be removed from the patient.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: FALLOPIAN TUBE CLIP/BAND
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14940437
• MDR Text Key: 295406085
• Report Number: 3011050570-2022-00087
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00821925032996
• UDI-Public: 00821925032996
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 005280-901
• Device Lot Number: KR107448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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
• Patient Outcome(s): Other