MAUDE Adverse Event Report: RAYNHAM CERTAS PLUS ELECTRONIC TOOL KIT

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.

• 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 Key: 10218397
• MDR Text Key: 200773378
• Report Number: 1226348-2020-00324
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• 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 Number: 828852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1