MAUDE Adverse Event Report: GYRUS ACMI, INC. EASYSUITE 4K INTEGRATION SYS MODEL 1200; DIGITAL IMAGE STORAGE

Model Number ISM-1005408

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The customer reported a poor-quality image on her olympus easy suite 4k integration system.According to the initial reporter, the image appears too small during procedure preparation and poses a risk to the patient due to poor visibility.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The customer called olympus technical assistance center (tac) personnel to report her issue.During the call, tac recommended changing out the monitor displays to see if this resolved the issue.The customer requested an olympus representative to come out on site and troubleshoot.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

• Brand Name: EASYSUITE 4K INTEGRATION SYS MODEL 1200
• Type of Device: DIGITAL IMAGE STORAGE
• Manufacturer (Section D): GYRUS ACMI, INC.; one monarch drive; suite 102; littleton MA 01460
• Manufacturer (Section G): GYRUS ACMI, INC.; one monarch drive; suite 102; littleton MA 01460
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17548860
• MDR Text Key: 321283800
• Report Number: 3003696010-2023-00009
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISM-1005408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2023
• 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