MAUDE Adverse Event Report: GYRUS ACMI, INC F-R BANDS,30 PROCEDURE; FALOPE RING BAND

Model Number FRB-30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The falope band remains implanted inside the patient.An investigation is ongoing to obtain additional information from the user facility regarding the reported event.

Event Description

The service center was informed that an expired falope band was implanted into a patient.The facility will continue to monitor the patient.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The legal manufacturer (lm) reviewed the content of this complaint.The lm reported that the cause of the event could not be conclusively determined.However, the most likely probable causes are as follows: a physical device inspection is unable to be performed.The expired product remains implanted in the patient.The customer reported that an expired falope ring band was implanted in a patient.The device remains implanted in the patient.Because of this no physical evaluation of the device is possible.The da stated that the device is an implantable device it can withstand longer time periods listed on the packaging.The packaging of the device was only tested and approved to withstand the indicated shelf life.The most notable hazard situation is infection in the patient.The patient should be monitored closely.A dhr review is unable to be performed as the lot number of the device is unknown.Olympus will continue to monitor the field performance of this device.

• Brand Name: F-R BANDS,30 PROCEDURE
• Type of Device: FALOPE RING BAND
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11302319
• MDR Text Key: 257215159
• Report Number: 3003790304-2021-00028
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00821925032972
• UDI-Public: 00821925032972
• Combination Product (y/n): N
• PMA/PMN Number: P870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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: FRB-30
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1