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

Model Number	MAJ-590
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during unspecified timing, the white residue like calcium hypochlorite remained in the tube of the subject device.The user has sterilized the subject device by non-olympus sterilization equipment sterrad, however the subject device is not compatible with sterilization by sterrad.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to any of olympus locations.It is determined that the cause of the indicated phenomenon is that it was not sterilized by the correct sterilization method.This product is not a device subject to sterrad sterilization, and it is judged that it is an event due to handling because the sterilization method is described in the instruction manual.If additional information becomes available, this report will be supplemented.

• Brand Name: INSUFFLATION TUBE
• Common Device Name: INSUFFLATION TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11327071
• Report Number: 8010047-2021-02629
• Device Sequence Number: 14098582
• Product Code: HIF
• UDI-Device Identifier: 04953170061318
• UDI-Public: 04953170061318
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: Other
• Device Model Number: MAJ-590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1