MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE BIOPSY VALVE (STERILE)

Model Number	MAJ-1555
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that during reprocessing, this single use biopsy valve, got stuck in biopsy channel.It was identified that the staff was reusing the valves which is affecting the integrity of the device.The staff, doctors, biomedical and ward manager were considering to start using reusable valves.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, from the information obtained, it was determined that the customer reused this product which is a single-use product.Although the device was not returned for an evaluation, it is likely that there was no device abnormality.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿disposal warning: after use, dispose of this instrument in an appropriate manner.If it is not properly disposed of, it could pose an infection-control risk.This instrument is a single-use, disposable item.Do not reuse or attempt to sterilize it.Reusing the instrument could pose an infection-control risk and cause malfunction.¿ this supplemental report includes a correction to d4 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to d8 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16624414
• Report Number: 3003637092-2023-00080
• Device Sequence Number: 20066567
• Product Code: FDS
• UDI-Device Identifier: 14953170247573
• UDI-Public: 14953170247573
• Combination Product (Y/N): N
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: MAJ-1555
• Device Lot Number: H1YA3822H1Y01
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown