MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION CLEANING ADAPTER

Model Number	MH-856
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Over a three-day timeframe, an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the reprocessing methods performed on the olympus scopes in-house.During this onsite visit, the suction cleaning adapter used in the cleaning of scopes was found to be incorrectly cleaned.There were no reports of patient harm associated with this event.This event is related to patient identifiers: (b)(4).
Additional Manufacturer Narrative
Date of event: (b)(6) 2021.The user facility was observed using the same suction cleaning adapter throughout the entire day without cleaning between uses (patient identifier (b)(4), model number pcf-h190dl, serial number (b)(4)).At the end of the day, the user facility would fill the adapter with detergent solution and let it soak in the detergent overnight.In the morning, the adapter would be flushed with air and then used for the rest of the day.The ess reviewed cleaning, disinfection, and sterilization for the devices.The customer was instructed to follow all olympus reprocessing procedures.The investigation is ongoing and follow up with the user facility is currently being performed.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
Additional information was received from the user facility.According to the user facility, after the final report is provided by olympus, this event will be addressed with personnel.
Additional Manufacturer Narrative
Updated field: b5.This supplemental report is being submitted to provide additional information 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.The device history record was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, the root cause could not be conclusively identified.It was likely the user facility did not train reprocessing staff sufficiently on handling and reprocessing in accordance with the instructions for use (ifu).Ifu (reprocessing manual) cautions the user against insufficient reprocessing as below: ¿1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.¿ the ifu also states the following on reprocessing steps for accessories: ¿chapter 6 reprocessing the accessories all accessories (except single-use accessories) must be reprocessed after each use to prevent an infection control risk" repeated attempts were performed to obtain additional information from the reporter but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.

• Brand Name: SUCTION CLEANING ADAPTER
• Common Device Name: SUCTION CLEANING ADAPTER
• 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: 12623772
• Report Number: 8010047-2021-13098
• Device Sequence Number: 1376047
• Product Code: FET
• UDI-Device Identifier: 04953170071270
• UDI-Public: 04953170071270
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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: MH-856
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 11/10/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/08/2021; 12/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PCF-H190DLSERIAL NUMBER (B)(6) ; SCOPEMODELS UNKNOWN
• Patient Sex: Unknown