MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERTAS PLUS ELECTRONIC TOOL KIT

Catalog Number	828852
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported the batteries of a certas plus electronic tool kit (id 828852) were changed, then the programmer would not turn on and became very hot.The batteries were removed and replaced with more new batteries and the same thing happened where it wouldn¿t turn on and became very hot.This happened while a patient was having their valve adjusted and the practitioner then had complete the adjustment with the manual toolkit.
Additional Manufacturer Narrative
Certas plus electronic tool kit was returned for evaluation: dhr - the batch record was reviewed for any anomalies or ncs related to the finished device, and none were identified.Failure analysis - new batteries were installed in the unit and it was confirmed that the unit did not turn on.The unit was then taken apart and a short was found on the controller board pcba.The location of the short is not evident.This short is causing the surface mount resettable fuse on the pcba to heat up.Root cause - the customer complaint is confirmed.Unable to determine root cause.Possible root causes include customer abuse / customer error (dropped unit, batteries installed backward) or latent manufacturing defects.Additional information received: was the programming time increase due to the issue? if yes, how long? "he was able to use the manual adjuster tool to change the patients shunt setting which was delayed by about 15 minutes.".
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS ELECTRONIC TOOL KIT
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20369186
• Report Number: 3014334038-2024-00204
• Device Sequence Number: 6869261
• Product Code: JXG
• UDI-Device Identifier: 10381780532897
• UDI-Public: 10381780532897
• Combination Product (Y/N): N
• PMA/510(K) Number: K181902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 828852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown