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U.S. Department of Health and Human Services

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

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GYRUS ACMI, INC. EASYSUITE 4K INTEGRATION SYS MODEL 1200; DIGITAL IMAGE STORAGE Back to Search Results
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.
 
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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 Key17548860
MDR Text Key321283800
Report Number3003696010-2023-00009
Device Sequence Number1
Product Code LMB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberISM-1005408
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/02/2023
Initial Date FDA Received08/15/2023
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 Number1
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