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

Model Number	FB-25K-1
Medical Device Problem Codes	Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called olympus to report that during reprocessing of the biopsy forceps, blood came out of the sheath after it was pulled out of the washing machine.The customer reported that the device tip and outer surface were cleaned with end fresh and disinfected in kaigen¿s clean top.The customer stated that ultrasonic cleaner was not used during the reprocessing of the device.There was no patient involvement, no harm or user injury reported due to the event.
Additional Manufacturer Narrative
It was reported that during the call to the olympus call center, the customer stated that they did not have an ultrasonic cleaner and was told to use clean top during cleaning by an unspecified source.The olympus call center representative advised the customer to use ultrasonic cleaner for thorough cleaning in the coil sheath of the biopsy forceps due to a gap between the wound wires that blood and fluid enter.The olympus call center representative also advise the customer that sterility of surgical instruments such as biopsy forceps required autoclave, and not by disinfection which is stated in the gastroenterological endoscopy engineers association.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer follow-up.B5- updated with customer information received.The device history record was unable to be reviewed for this device since the lot number was not provided.However, a review of manufacturing records for (b)(6) 2021 to (b)(6) 2022 found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause of the foreign material exiting the sheath was likely from incorrect reprocessing after the previous procedure per the instructions for use.The specific root cause of the incorrect reprocessing at the facility could not be determined at this time.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Customer stated they did not perform a culture test.They confirmed they did not have any reports of infections.The device has been properly reprocessed and will not be returned for evaluation.

• 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: 13517557
• Report Number: 8010047-2022-02846
• Device Sequence Number: 19885397
• Product Code: EOQ
• UDI-Device Identifier: 04953170030055
• UDI-Public: 04953170030055
• 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): 03/14/2022

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-25K-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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