MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. SUCTION VALVE

Model Number	MH-443
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the suction valve was stuck in the suction channel.The issue was found during maintenance.The device was intended to be used in an unknown diagnostic procedure, which was completed with a similar device.There were no reports of patient harm.Inspection and testing of the returned device found the suction button did not come off, a foreign object was caught in the suction channel, and foreign material was attached between top and spring.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.Patient identifier: (b)(6).Captures complaint on (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Updated fields: h6 and h10.The manufacture date cannot be identified at this time since the serial/lot was not provided.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, there was deviation from the instructions for use (ifu) in reprocessing steps for the location where the foreign material remained.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: - gif/cf/pcf-290 series operation manual chapter 3 preparation and inspection - gif/cf/pcf-290 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) 5.4 leakage testing of the endoscope -gif/cf/pcf-290 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) - gif/cf/pcf-290 series reprocessing manual chapter 6 reprocessing the accessories.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16572963
• Report Number: 9610595-2023-04676
• Device Sequence Number: 20657807
• Product Code: FDS
• UDI-Device Identifier: 04953170071256
• UDI-Public: 04953170071256
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: MH-443
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• 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: 02/19/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown