MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SHEATH SECTION

Model Number MAJ-655

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the event date, it was found no irregularities.Omsc checked the instruction manuals, but there were no problems with the contents.

Event Description

It was reported that the user has not been following the ifu reprocessing methods.20 devices were affected.There was no patient injury reported.On (b)(4) 2021, olympus medical systems corp.(omsc) judged that the reported event was reportable.This is the 20th one of twenty reports.

• Brand Name: SHEATH SECTION
• Type of Device: SHEATH
• 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: 11290685
• MDR Text Key: 232216046
• Report Number: 8010047-2021-02334
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170062445
• UDI-Public: 04953170062445
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2021

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
• Device Operator: Health Professional
• Device Model Number: MAJ-655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1