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

Model Number	FB-55CR-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, during a diagnostic thoracoscopic exploration biopsy procedure, after the biopsy sampling, the jaw of the device was found to be broken.A search of the patient¿s pleural cavity revealed no presence of any broken pieces.The broken pieces were found in the sediment of the pleural fluid suction collection bag.There is no harm or adverse impact to the patient.
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
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.A definitive root cause could not be determined since the device was not sent for evaluation.Based on the results of the investigation, the following are probable causes of the failure: 1.Insufficient cleaning of the device after use left foreign material and/or detergent solution on the arm of the cups.2.The residue corroded the arm and weakened it.3.The weakened arm broke off when a force was applied to it during handling.The event can be detected/prevented by following the instructions for use which states: ·before use, confirm that the distal tip of the forceps is not corroded, dented or discolored, and that the cups can be opened and closed smoothly.Using forceps that are damaged or not working properly may result in one or more of its components falling off inside the patient.If a component falls off of the distal end, or if operation of the cups suddenly becomes more difficult, immediately stop the procedure.Carefully withdraw the forceps together with the endoscope to avoid causing injury within the body cavity.Retrieve any parts that have fallen off inside the patient using another grasping forceps.·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 of this device.

• Brand Name: ROTATABLE BIOPSY FORCEPS
• Common Device Name: ROTATABLE 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: 14759892
• Report Number: 8010047-2022-10483
• Device Sequence Number: 1349606
• Product Code: EOQ
• UDI-Device Identifier: 04953170078217
• UDI-Public: 04953170078217
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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-55CR-1
• Device Lot Number: K1Z20-3299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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 Age: 28 YR
• Patient Sex: Male