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

Model Number MAJ-590

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 233488521
• Report Number: 8010047-2021-02629
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170061318
• UDI-Public: 04953170061318
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MAJ-590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1