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

Model Number	FB-52K-1
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found discolorations on the device which were removed by brush cleaning.From this, it was determined that the discolorations were not rust, but the adhesion of foreign materials.Additional evaluation findings are as follows: when the slider was operated, the grasping jaws could be opened and closed, but there was a sense of resistance.After the cups opened facing the front, pressing the slider further caused the cups to swing and face sideways.When force was applied to the cup, the swing was smooth and there were no abnormalities.There were dark brown discolorations in the arm of the caps (a part of the linkage mechanism at the distal end); parts were not missing.After applying lubricant to the tip of the insertion part, the opening and closing of the cup became smoother.There was no abnormality in the insertion portion.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility reported to olympus that during a procedure, the olympus, model fb-52k-1, biopsy forceps opened cup was bent and signs of rust were noted.In addition, it was reported that opening/closing the cup was "heavy." the intended procedure was completed.There was no patient impact, associated with the problem, reported to olympus.The device was returned to olympus.Upon inspection and testing of the returned device, evidence of foreign material was found.This report is submitted due to the finding of the presence of foreign material adhered to the device, identified during the manufacturer's evaluation of the device.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional event related information.
Event or Problem Description
The user facility reported problems that the biopsy forceps opened cup was bent, signs of rust were noted and opening/closing the cup was "heavy" were found on pre-use inspection of the device.The device was not used for the intended procedure; the intended procedure was completed using another similar device.There have been no reports of patient infection or injury received by olympus, associated with use of the device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.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, a definitive root cause could not be determined.However, it is likely that the adhesion of foreign matter is due to insufficient cleaning, or that it has not been sufficiently cleaned due to the passage of time after use.The following information is stated in the instructions for use (ifu): ¿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.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 could be damaged.¿ 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 (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: 15813006
• Report Number: 9614641-2022-00633
• Device Sequence Number: 7015185
• Product Code: EOQ
• UDI-Device Identifier: 04953170030543
• UDI-Public: 04953170030543
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962555
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2022

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-52K-1
• Device Lot Number: K1X07-3351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2022
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 12/07/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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