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

Model Number	FB-231D
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the disposable biopsy forceps were attempted to be used and the tip cup did not open.The issue was found during an unknown diagnostic procedure.The customer attempted to use a second disposable biopsy forceps, but had the same problem, and the procedure was completed using a third disposable biopsy forceps.The device was returned for evaluation.During the device evaluation, it was found that two operating wires were broken and there were missing parts.There were no reports of patient harm or injury.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the reportable finding documented in b5, the non-reportable evaluation finding was: the operation wire fixing hole of the cup was scratched when the operating wire was pulled with excessive force.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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.The device was visually inspected, and functional testing was performed.Based on the results of the investigation, the event was confirmed, and the device did not meet the standard specifications.The following were found: two operating wires had come loose from the operating wire fixing holes in the cup.The cups could not be opened or closed as the joint portions of two of the manipulation wires had detached from the forceps linkage.Two operating wires were broken and had missing parts.The two manipulation wires were broken and had a defect.The forceps linkage was closely inspected; the periphery of the joint holes was found to be scratched.The scratches were likely caused by excessive force used to pull the manipulation wires.There were no other abnormalities such as buckling of the insertion site.There were no other abnormalities such as kinks of the insertion part.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: instruction manual (picture number: gk6287, edition number 17) and instruction manual (drawing number: gk6287 revision number: 17): do not pull out the biopsy forceps while the endoscope is angled.The operating wire of the biopsy forceps may come off the cup.If the device is used with the operation wire disconnected, the disconnected wire may protrude and cause perforation, bleeding, or mucosal damage.If the operating wire comes off the cup, please stop using it immediately.If the operating wire comes off the cup, the operating feeling may change, such as the slider losing resistance or getting caught.If the feeling of operation changes, please check that the operation wire has not come off the cup.If the operation wire comes off after inserting the biopsy forceps into the endoscope, pull the slider all the way to your fingertips, pull the biopsy forceps near the tip of the endoscope, and then attach the biopsy forceps and endoscope together, while watching the endoscopic image, pull it out being careful not to damage the inside of the body cavity.Do not forcefully insert the product, do not insert it without the cup closed, or do not insert it suddenly.They may suddenly protrude from the tip of the endoscope, leading to perforation, major bleeding, mucosal damage, or damage to the endoscope or biopsy forceps.If insertion is difficult due to strong resistance, return the angle of the endoscope or forceps stand to a point where insertion is possible without strain.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 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.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: 18409339
• Report Number: 9614641-2023-02004
• Device Sequence Number: 14186081
• 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): 02/22/2024

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: 34T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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