MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-211D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus; however, evaluation has not yet begun.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
The customer reported to olympus that the disposable biopsy forceps jaws broke inside the patient's lungs.On examination, an internal wire protrudes from the forceps when the jaws open, potentially leading to unintended injury to the patient's airway.No part of the forceps fell into the patient's lungs.The procedure was completed using a similar device after a 4-minute delay.The patient was discharged from the hospital.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) final investigation and device evaluation.Updated fields: h3, h6 and h10.The h4 field was corrected based on information provided in the lm investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device evaluation found one of the operating wires extended when the slider was pushed.Also, the extended operating wire was detached from the joint hole of the cup.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.Based on the results of the investigation, it is likely the malfunctioned occurred due to the following: 1) factors such as the cup was grasping hard objects prevented the cup from opening and closing smoothly.2) the device was withdrawn from the endoscope while the slider was excessively pulled due to 1).This applied a tensile force to the area where near the caulked area of the operating wire.3) due to the tensile force in state of the above description stated in 2), the operating wire contributed to deformation of the joint hole of the operating wire of the cup.As a result, the joint hole was torn.4) the operating wire was detached from the torn joint hole of the operating wire.5) the detached operating wire was extended when the sider was pushed.However, a definitive root cause for the event could not be determined.The event can be detected/prevented by following the instructions for use which state: ¿do not withdraw the biopsy forceps while the endoscope is angulated.Doing so could cause the manipulation wire to detach from the cups.A part of manipulation wire could be damaged and detached to fall off into the patient¿s body or the wire may stick out and damage the endoscope and/or cause bleeding or damage the mucous membrane.Using the equipment with a detached wire could cause bleeding or damage to the mucous membrane.Using the equipment with a detached wire could cause bleeding or damage to the mucous membrane.¿if the manipulation wire becomes detached from the cups, immediately stop using the instrument.With the wire detached, you may feel little or no resistance when moving the slider, and your impression of the manipulation of the instrument may differ significantly from what is actually taking place.If you notice any major changes in manipulation, check whether or not the wire has become detached from the cups.¿if the manipulation wire becomes detached while the biopsy forceps are inserted in the endoscope, first move the slider all the way in the proximal direction in order that the cups may come as close to the distal end of the endoscope as possible.Then, withdraw the biopsy forceps and the endoscope together from the patient¿s body with extreme care to avoid causing patient injury.At the same time, make sure that no part of the manipulation wire has fallen into the patient¿s body.¿do not force the instrument if resistance to insertion is encountered.Reduce the endoscope¿s angulation (or lower the forceps elevator if applicable) until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.In addition, the following non-reportable malfunctions were found during the device evaluation: the caulked area of the operating wire was not broken.The joint hole of the operating wire of the cup was deformed and torn.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16968180
• Report Number: 9614641-2023-00709
• Device Sequence Number: 12073220
• Product Code: EOQ
• UDI-Device Identifier: 04953170389535
• UDI-Public: 04953170389535
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: FB-211D
• Device Lot Number: 1ZV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown