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

Model Number	005280-901
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
The bands were found and were able to be removed from the patient.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Common Device Name: 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
• Report Number: 3011050570-2022-00087
• Device Sequence Number: 20377905
• Product Code: KNH
• UDI-Device Identifier: 00821925032996
• UDI-Public: 00821925032996
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown