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

Model Number	FB-19K-1
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that the biopsy forceps cup failed to open.The event occurred during preparation for use and a similar device was used to complete the operation.During a standard service inspection of the customer returned device, foreign matter was adhered to the forceps.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device was returned for investigation.Upon evaluation of the device, foreign matter was adhered to the forceps.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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 foreign matter that had adhered to the forceps.The investigation determined, that the cups failed to open and close, because foreign materials had adhered to the linkage mechanism.A definitive root cause for this issue was not established.However, it is probable that issue occurred, because of insufficient cleaning.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu), which state the following: ¿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: 14427387
• Report Number: 8010047-2022-08368
• Device Sequence Number: 20205706
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: K1819-1400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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