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

Model Number	MAJ-209
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
On behalf of the customer, an olympus customer service agent reported an out of box failure for the single use suction valve (sterile) device.The shipping provider (ups) delivered a package containing the subject device; however, the box was soaked and damaged so the customer refused the shipment.A few days later, ups delivered the device in a ups repackaged box.The customer accepted the packaged, and upon opening it found all the items were damaged from the original order.There was no patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the legal manufacture.H4: based on the 3 digit lot number provided (22h), the manufacturing date of the device was in the month of february or march 2022 but a specific date could not be identified.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.Please see updates to d8, h3, h4, h6 and h10.The device was returned to olympus for inspection, and the customer's complaint was confirmed.A visual inspection on the boxes was completed and it was found that the box contained 60 pieces but only 2 of the original packaging was returned.Box one had heavy impact and water damage on the top and bottom of the original packaging.Box 2 had little damage with only a slight dent on the left corner on the front of the package.The device inside the boxes showed no indication of damage and appeared unopened and unused.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the cause of the stains and damage to the box is a handling problem such as delivery after shipment from the factory.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION 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: 15825195
• Report Number: 3003637092-2022-00083
• Device Sequence Number: 6157359
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K201758
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023

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: MAJ-209
• Device Lot Number: 22H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 04/23/2023; 05/30/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 05/17/2023; 05/30/2023
• 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