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

Model Number	FB-231D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed due to a biopsy forceps malfunction being found; the connection between the cup and the wire had come off.In addition, during inspection and testing of the returned device, the coil at the base of the insertion part was exposed by extending approximately 110mm.The cups could not be opened or closed, as the joint portions of two of the manipulation wires had detached from the forceps linkage.The operation wire did not come out from the tip of the insertion portion even when the slider was fully pushed.The periphery of the joint holes were found to be scratched, which was likely caused by excessive force used to pull the manipulation wires.The insertion portion was kinked in two places.There were burrs on the outer sheath.There were no abnormalities observed in the grasping portion and the outer diameter around it.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that there was an issue while using the disposable biopsy forceps.When the cup was inserted through the forceps opening, the cup was closed and the mucous membrane was grasped, and the green covering sheath in front of the operation part was peeled off, exposing the internal coil.When it was pulled out for the first time, it was pulled out by holding the green sheath part.When the customer pulled it out from the respiratory scope, it was pulled out by the operation part; there was a sense of resistance, and the sheath came off the operation part.The (diagnostic) biopsy procedure was completed with the same set of equipment and there was no patient harm associated with the event.The device was returned and evaluated, and a biopsy forceps malfunction was found; the connection between the cup and the wire had come off.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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.Based on the results of the investigation, the cause of the resistance during withdrawal was not identified, as no abnormalities that would lead to resistance during withdrawal from the endoscope could be found in the actual product.According to the results of the investigation of the actual product, when the biopsy forceps were removed from the endoscope, the operating part was pulled vigorously, and a strong load was applied to the product beyond its strength, causing the coil to stretch and the operating wire to break.It is assumed that the operation wire came off from the operation wire fixing hole of the cup.Based on the results of reproduction studies of similar events in the past, it was found that the sheath was pulled out while the sheath part protruding from the endoscope was bent, causing the sheath to get caught in the tip of the endoscope and become split.Guessed.It is possible that the kink of the insertion portion occurred due to a problem in the handling of the user.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." correction: per the legal manufacturer, there is no potential for this issue (parts broke off; the connection between the cup and the wire has come off) to cause or contribute to death or serious injury if the malfunction were to recur.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15544080
• Report Number: 9614641-2022-00416
• Device Sequence Number: 5593855
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: FB-231D
• Device Lot Number: 26K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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 Sex: Unknown