MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. IMAGE MANAGEMENT HUB

Model Number IMH-20

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The subject imh-20 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device, and the reported event was not reproduced.Omsc checked the log file of the subject device and confirmed the following the records.The operation log after 14:31 on (b)(6) 2019 is not recorded on the subject device.The system shut down at 15:30 on (b)(6) 2019.The subject device restarted at 17:34 on (b)(6) 2019.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Since the event was not reproduced, the exact cause has been unknown; however, the following are supposed to be the cause.A malfunction occurred temporarily on the motherboard or memory of the subject device.The instruction manual of the subject device states the corresponding method in case of an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the unspecified procedure with the imh-20, the drive indicator on the front panel of the subject device was lit orange and the endoscopic images could not recorded on the subject device.The user replaced the subject device to another unspecified system including the unspecified recorder to complete the procedure.After the procedure, the user turned on the subject device, the subject device worked properly.There was no report of the patient injury other than replacing the device.

• Brand Name: IMAGE MANAGEMENT HUB
• Type of Device: IMAGE MANAGEMENT HUB
• 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
• MDR Report Key: 9243543
• MDR Text Key: 213501657
• Report Number: 8010047-2019-03726
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMH-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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