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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CERTAS PLUS ELECTRONIC TOOL KIT

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RAYNHAM CERTAS PLUS ELECTRONIC TOOL KIT Back to Search Results
Catalog Number 828852
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
A physician reported that after the procedure the setting of the certas valve could not be changed by the etk (electronic tool kit).There was a slight gap between the display and the valve itself.Therefore, it was changed to another one with no adverse consequences to the patient.
 
Manufacturer Narrative
Updated fields: d10, g4, g7, h2, h3, h6, h10 unique device identification (udi):(b)(4).The certas tool kit was not returned therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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Brand Name
CERTAS PLUS ELECTRONIC TOOL KIT
Type of Device
CERTAS PLUS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key10218397
MDR Text Key200773378
Report Number1226348-2020-00324
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/02/2020
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 Catalogue Number828852
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2020
Initial Date FDA Received07/01/2020
Supplement Dates Manufacturer Received07/08/2020
Supplement Dates FDA Received07/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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