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

Model Number	MAJ-1555
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacturer date is unknown since the lot number was not provided.The subject device was discarded at the user facility.The device history record was not able to be reviewed for the subject device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Factory test unit maj-1555 (lot: 1h2716) was tested and attached to the factory test scope (tjf-q190v, sn: (b)(4) and inserted terumo's syringe to check for leaks, but no leaks were identified.Based on the legal manufacturer's investigation, a definitive root cause could not be identified.However, there are three possible causes: -upon attaching maj-155, the housing broke off.-syringe was not sufficiently inserted.-syringe was not straight when inserted.The maj-1555 is not compatible with the lure lock syringe.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported dissatisfaction with the functionality of the subject device (biopsy valve).It was reported the valve would not fit the luer lock syringe and when using it with a pointed syringe the water would come out from all sides which means that water cannot be irrigated through the channel, preventing the correct cleaning of the mucosa to continue the procedure.The reported issue occurred during an unspecified diagnostic procedure.The intended procedure was completed using the subject device.There was no patient or user injury reported due to the event.This report is being submitted due to water coming out of the biopsy valve.

• 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 Contact: masaharu hirose ; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0-182 ; JA 190-0182 ; 426422891
• MDR Report Key: 15583893
• Report Number: 3003637092-2022-00064
• Device Sequence Number: 8035399
• Product Code: FDS
• UDI-Device Identifier: 14953170247573
• UDI-Public: 14953170247573
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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: MAJ-1555
• 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: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown