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

Model Number	FB-41ST-1
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer returned the device for evaluation and repair of the device cup not opening or closing observed upon inspection.There is no patient involvement as there no procedure taking place on that day and no harm reported to any patient.The device was used in approximately two or three cases.Upon evaluation of the returned device, it was observed that there is foreign material adhering to the arms of the cup of the device, which is the linkage mechanism at the distal end.This medwatch is being submitted for the presence of foreign material in the device as observed during device evaluation.At the facility, cleaning of the device is performed with sakura seiki¿s ultrasonic or reduced pressure boiling.Sterilization done by autoclave.
Additional Manufacturer Narrative
Customer returned four devices (different lots) with the same issue of cups not opening occurring on the same day or within one day.These devices are captured in medwatches with patient identifiers (b)(6).This medwatch is for patient identifier (b)(6).The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that there is foreign material adhering to the arms of the cup of the device, which is the linkage mechanism at the distal end.The cup remained close and did not open when the slider was operated.Ultrasonic cleaning of the forceps tip did not remove the foreign material and did not open the cup.After inserting tweezers into the gap of the cup to open it, applying lubricant, the cup could be opened and closed.The insertion portion at the base of the handle was buckled.There were no abnormalities observed.
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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed that the cups do not open and close because foreign material was adhered to the linkage mechanism.It is likely that the adhesion of foreign matter is due to insufficient cleaning, in addition.It is also likely that the kink of the insertion portion occurred due to a handling/user error.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿reprocess the instrument immediately after use by immersing it in a neutral, low-foaming, medical-grade detergent solution, then following the cleaning and sterilization procedures in this chapter.Failure to reprocess the instrument immediately after use or using another type of detergent may cause corrosion at the instrument¿s distal end.This could cause components to fall off during use and may interfere with operation of the cups.¿ ¿the reprocessing procedures described in this manual should be completed the same day the instrument has been used.If reprocessing is delayed, residual organic debris will solidify, and it may be difficult to effectively reprocess the instrument.¿ ¿when inserting the instrument into the endoscope, hold it close to the biopsy valve or t-plug and keep it as straight as possible relative to the biopsy valve or t-plug.Otherwise, the insertion portion of the instrument could be damaged.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Do not forcefully squeeze, wipe or scrub the instrument.This could cause damage to the instrument or result in reduced performance.¿ ¿lubrication: 1.Immerse the insertion portion in the lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the cups two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry.¿ this supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: 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: 15277839
• Report Number: 9614641-2022-00185
• Device Sequence Number: 6478506
• Product Code: NWW
• UDI-Device Identifier: 04953170048708
• UDI-Public: 04953170048708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CLASS1-EXMPT
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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-41ST-1
• Device Lot Number: K9Z10 0381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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