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

Model Number	MAJ-1555
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The olympus endoscopy support specialist (ess) observed the customer had been reprocessing disposable forceps plugs, instead of correctly discarding them after single use.The olympus ess reviewed the proper cleaning, disinfection and sterilization reprocessing steps and covered pre-cleaning, leakage testing, manual cleaning, and high-level disinfecting with the customer reprocessing technicians.In additional, the olympus ess informed the customer reprocessing technicians that the maj-1555 is a single use accessory and to be discarded after use.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The user facility requested a reprocessing in-service for the single use biopsy valve (sterile).An olympus endoscopy support specialist (ess) visited the customer and noted during the in-service, the customer was not discarding single use biopsy but instead reprocessing them.It was reported that the customer was not using mh-948 endoscope aw channel cleaning adapter for precleaning of equipment.There was no patient involvement, no harm or user injury reported due to the event.Additional information from the user facility confirmed that the biopsy channel covers were cleaned and sterilized for reprocess training purposes and the biopsy channel covers were not reuse.
Additional Manufacturer Narrative
This supplemental report is being submitted, to provide the legal manufacturer's investigation.The device history records (dhr) for this device could not be reviewed, since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was determined, the probable cause was incorrect reprocessing of the device and not discarding it as intended.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Common Device Name: BIOPSY VALVE
• 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: 13653764
• Report Number: 8010047-2022-03785
• Device Sequence Number: 14073843
• Product Code: FDS
• UDI-Device Identifier: 14953170247573
• UDI-Public: 14953170247573
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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