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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K

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DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K Back to Search Results
Model Number EVO4K220
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in (b)(6) that preoperatively to an unknown surgery on (b)(6) 2021, it was observed that the image management system- evolution 4k device did not display image on the screen.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
Type of Device
IMAGE MANAGEMENT
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12268747
MDR Text Key264794199
Report Number1221934-2021-02365
Device Sequence Number1
Product Code LMB
UDI-Device Identifier00817613020543
UDI-Public00817613020543
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/21/2021
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 NumberEVO4K220
Device Catalogue Number242326
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/21/2021
Initial Date FDA Received08/03/2021
Supplement Dates Manufacturer Received01/24/2022
Supplement Dates FDA Received01/24/2022
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 Unknown
Patient Sequence Number1
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