MAUDE Adverse Event Report: GYRUS ACMI, INC. F-R BANDS,30 PROCEDURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number FRB-30

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during an unspecified procedure using falope ring bands, the physician misfired one falope ring band and it was left in the patient.There are no reported adverse effects to the patient as a result of this occurrence.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the customer.A follow up report will be submitted upon completion of the investigation and/or new information received.

Event Description

The following additional information regarding the reported event was received from the customer: the procedure being performed was a laparoscopic attempted bilateral tubal ligation with falope-rings.The patient was discharged after the procedure.There is no plan to retrieve the falope-ring from the patient's abdomen.The patient has not experienced any adverse effects as a result of this occurrence.Three packages of falope-rings were opened during the procedure (lot kr973924, 324909.Mah 417884).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.The applicator or other ring bands were not returned for evaluation.Therefore, the root cause could not be determined.The event is addressed in the instructions for use which state: "falope-ring band(s) may be inadvertently dropped into the abdominal cavity and not recovered.No untoward effects have been associated with unrecovered devices." olympus will continue to monitor field performance for this device.

• Brand Name: F-R BANDS,30 PROCEDURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15493547
• MDR Text Key: 306273317
• Report Number: 3003790304-2022-00253
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00821925032972
• UDI-Public: 00821925032972
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FRB-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 117 KG