MAUDE Adverse Event Report: GYRUS ACMI, INC FLEXIBLE BIOPSY CUP 3FR 115CM

Model Number	FBC-3115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the flexible biopsy cup 3fr 115cm cup broke after one use during a therapeutic procedure.Attempts to retrieve additional information from the customer are in progress.There were no reports of patient death, harm or injuries related to this event.
Additional Manufacturer Narrative
The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 28-feb-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was received in a clear plastic bag without it's original packaging.At first glance, the inner spring was wavy, not straight.When actuating the device the movement was rigid and not smooth.The claw was able to fully open and close with a decent amount of force.The reported failure of "broke" cannot be confirmed.The customer provided a picture of the device that included an arrow pointing to the "stopper" area of the device.Based on the results of the investigation, it is likely the customer did not understand the screw was actually used as a stopper and the gap created by the screw was intentional.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer confirmed the device was used once and it was already broken.The device did not touch a patient because it was broken.The date and procedure type are unknown.

• Brand Name: FLEXIBLE BIOPSY CUP 3FR 115CM
• Common Device Name: BIOPSY CUP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough NH 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13978257
• Report Number: 8010047-2022-05532
• Device Sequence Number: 12232647
• Product Code: FCL
• UDI-Device Identifier: 00821925003811
• UDI-Public: 00821925003811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-FCL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: FBC-3115
• Device Lot Number: 5053514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown