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

Model Number	FRB-30
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 3003790304-2022-00253
• Device Sequence Number: 16611913
• Product Code: KNH
• UDI-Device Identifier: 00821925032972
• UDI-Public: 00821925032972
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P870076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 06/05/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/04/2022; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 117 KG