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

Model Number	MAJ-1218
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
During the otorhinolaryngology outpatient examination using the single use biopsy valve with the rhinolaryngoscope, a black piece of rubber fell into the field of view.The black rubber piece was collected using biopsy forceps and the procedure was completed with no effect on the diagnosis or treatment outcome.The fallen piece was 1 to 2mm and had no sharp parts.The procedure was delayed a few minutes while the foreign body was collected with biopsy forceps.The device was inspected before use with no abnormality.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and it was confirmed that the rubber valve of the biopsy valve was damaged.Since the subject device was damaged, a sample from a different lot was used to confirm the reproduction.It was confirmed that if the syringe and the endo-therapy accessory are inserted and removed from this product attached to an endoscope while the syringe and the endo-therapy accessory are tilted, the rubber valve will be damaged and fall off.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the following was determined: when the syringe and the endo-therapy accessory are inserted and removed from this product attached to an endoscope while the syringe and the endo-therapy accessory are tilted, the rubber valve will be damaged and fall off.It is likely that the repeated insertion and removal of the syringe and the endo-therapy accessory pushed the pieces of the rubber valve into the endoscope's suction channel, causing the pieces to fall off and into the patient's body.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿9.4 feeding and aspirating solution with a syringe: insert a syringe firmly and hold it perpendicular to the valve.Feed or aspirate solution from the syringe as necessary.¿ ¿9.5 inserting and withdrawing the endo-therapy accessories: insert the endo-therapy accessory into the valve as straight as possible.Angled insertion and withdrawal of the endo-therapy accessory can cause excessive resistance, and the endo-therapy accessory or biopsy valve could be damaged.¿ furthermore, it was confirmed that the maj-1218 medical device package insert states that inserting and removing the syringe, or the endo-therapy accessory angled from the biopsy valve is an incorrect usage method.It was also confirmed that this may cause the forceps plug to break and pieces to fall into the patient body.This supplemental report includes an update to h3, and a correction to h4 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Common Device Name: SINGLE USE 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: 19084854
• Report Number: 3003637092-2024-00055
• Device Sequence Number: 7576108
• Product Code: EOB
• UDI-Device Identifier: 14953170154291
• UDI-Public: 14953170154291
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061313
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1218
• Device Lot Number: H3201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHINOLARYNGOSCOPE (ENF-VT3).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown