MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BIOPSY VALVE (STERILE)

Model Number MAJ-1555

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc could not review the manufacturing history record (dhr) because the lot number was not provided, omsc confirmed with another but the similar device that the reported event.Omsc confirmed that the subject device was opens and close properly without any problems.The exact cause of the reported event could not be conclusively determined.However, there was the possibility that the reported phenomenon might be attributed to the damage of the subject device or the inappropriate user handling.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the subject device opened easily during an unspecified procedure.There was no report of patient injury associated with this event.

• Brand Name: SINGLE USE BIOPSY VALVE (STERILE)
• Type of Device: BIOPSY VALVE
• 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: 10999771
• MDR Text Key: 227270837
• Report Number: 8010047-2020-10273
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 14953170247573
• UDI-Public: 14953170247573
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051645
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-1555
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1