MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY FORCEPS

Model Number	FB-19C-1
Medical Device Problem Codes	Contamination (1120); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that there was foreign material adhering to the link mechanism of the device.This was preventing the cup from opening.By ultrasonically cleaning the tip of the forceps, foreign matter was removed and the cup can be opened.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
As reported for this event by the customer, during pre-use inspection, the device cup did not open.There is no patient involvement and no harm reported to any patient.Another device was used for the intended procedure.Upon evaluation of the returned device, it was observed that there was foreign material adhering to the link mechanism of the device.This was preventing the cup from opening.
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, a definitive root cause could not be established.It is presumed 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 instructions for use (ifu) states the following related to the suggested phenomenon: "·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.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." olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14209271
• Report Number: 8010047-2022-07039
• Device Sequence Number: 19882087
• Product Code: EOQ
• UDI-Device Identifier: 04953170029585
• UDI-Public: 04953170029585
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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
• Device Model Number: FB-19C-1
• Device Lot Number: K5918-3106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2015
• 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