MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ATTACHMENT "MAJ-891", INSULATED; UNKNOWN

Model Number A02917A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

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 that the subject device was damaged in the unspecified same part without extra force at any time.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc could not review the manufacturing history (dhr) of the subject device because it was an accessories outside the scope of the dhr review.The exact cause of the reported event could not be conclusively determined.However there was the possibility that this phenomenon was attributed to the chemical damage due to the insufficient rinsing while the reprocessing and/or applying the excessive force to the subject device by the user.If additional information becomes available, this report will be supplemented.

• Brand Name: ATTACHMENT "MAJ-891", INSULATED
• Type of Device: UNKNOWN
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9902533
• MDR Text Key: 221299686
• Report Number: 8010047-2020-01898
• Device Sequence Number: 1
• Product Code: FEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A02917A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1