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

Model Number ISM-1005408

Device Problem No Display/Image (1183)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported that 4 easysuite systems (model ism-1005408) are having the same video displaying problems in which the bottom right part of the image is not displaying.Per the report, one part of the image was not showing up.The issue was found during preparation for use.There were no reports of patient harm.This event includes 4 reports addressing the reported issue of the 4 easysuite systems.Report with patient identifiers: (b)(6) model ism-1005408- sn: (b)(6); (b)(6) model ism-1005408- sn : (b)(6); (b)(6) model ism-1005408- sn: (b)(6); (b)(6) model ism-1005408- sn: (b)(6).This report being submitted is for report with patient identifier (b)(6) model ism-1005408- sn: (b)(6).

Manufacturer Narrative

The device is not expected to be returned for evaluation.Technical assistance center (tac) communication with the customer noted that this an ongoing issue that might be related to the fiber cabling in the sites operating room (or).The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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: 17456502
• MDR Text Key: 320382725
• Report Number: 3003696010-2023-00006
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• 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
• Treatment: (B)(6); (B)(6); (B)(6)