MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION TUBE

Model Number	MAJ-591
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer suspected device was returned for investigation.The olympus service center was unable to reproduce the reported event during inspection and testing.Upon evaluation of the returned device, there was no abnormality in the appearance and no abnormality when connecting and operating according to the instruction manual.According to the device evaluation, the returned device serial number was unknown.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
A user facility reported to olympus, the suction tube experienced pneumoperitoneum pressure decreased.The event occurred during an unknown therapeutic procedure.According to the initial reporter, the smoke exhaust function was activated, and the pressure decreased even though the foot switch was not engaged.It was reported that, after the air was sent, the pressure was released, and the procedure was continued and completed.The customer reported that this issue has occurred several times.There was no report of patient harm or user injury associated with this event.This complaint is related to patient identifiers; (b)(6).
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 since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The reported event was unable to be duplicated during the device evaluation.Based on the results of the investigation, it¿s likely the reported event was related to factors other than the device settings and device.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION TUBE
• Common Device Name: SUCTION TUBE
• 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: 15010085
• Report Number: 8010047-2022-11895
• Device Sequence Number: 2316469
• Product Code: HIF
• UDI-Device Identifier: 04953170061325
• UDI-Public: 04953170061325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K014166
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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-591
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-1939; UHI-4
• Patient Sex: Unknown