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 Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Estimation inspected the device and determined that a software update was required.No physical damage was noted.The instruction manual states ¿before using this instrument, be sure to inspect and set it up as described in this chapter.Also inspect the ancillary equipment to be used in combination with this instrument as described in the instruction manuals for the equipment.If any irregularity is observed with this instrument, do not use it and take remedial actions as described in chapter 8, ¿troubleshooting¿.If this cannot restore the normal operation, contact olympus.Using this instrument while an irregularity is observed does not only result in malfunction but may also cause an electric shock, injury and/or fire.¿.

Event Description

The service center was informed that during a laparoscopic procedure, the image management hub would periodically shut off during recording.The pictures were not recorded and the doctor lost all of the images.There was no damage or abnormalities noted upon inspection.There were no error messages received.The intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Please see the updates in sections: g4, g7, h2 and h10.Additional evaluation findings show the imh-20 tested and passed all functional tests.The service personnel was unable to duplicate the reported complaint.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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
• MDR Report Key: 9913144
• MDR Text Key: 198914010
• Report Number: 8010047-2020-01918
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMH-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1