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

Model Number	FB-19K-1
Medical Device Problem Codes	Contamination (1120); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that it was observed that the arm of the cup (a part of the linkage mechanism at the distal end) were broken off.The broken arms had brown foreign materials around the broken place.The broken arms were not missing.Brittle fracture due to corrosion was observed on the broken part.The gripper does not open or close when the slider is operated, as the link mechanism is broken.Also, the insertion portion was buckled at approximately 640 mm and 670 mm from the tip.The user¿s complaint of cup being broken is confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
Customer returned the device for evaluation and repair for the cup at the tip being broken during reprocessing after first time use of the device.There is no patient involvement.The previous biopsy procedure was successfully completed.The reprocessing had been performed by immersion in disinfectant, immersion time and disinfectant type is unknown.Upon evaluation of the returned device, it was observed that the arm of the cup (a part of the linkage mechanism at the distal end) were broken.The broken arms had brown foreign materials around the broken place.The broken arms were not missing.This medwatch is being submitted for the foreign material found on the device during device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the foreign matter adhesion before use/after cleaning could not be identified.The event can be detected/prevented by following the instructions for use 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.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: 15522894
• Report Number: 9614641-2022-00399
• Device Sequence Number: 19462537
• Product Code: EOQ
• UDI-Device Identifier: 04953170029608
• UDI-Public: 04953170029608
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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-19K-1
• Device Lot Number: K7116 2711
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown