MAUDE Adverse Event Report: RAYNHAM CERTAS PLUS ELECTRONIC TOOL KIT

Catalog Number	828852
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported the codman certas plus electronic tool kit had excessive heat.During outpatient use, the battery of the electronic tool kit was replaced due to battery depletion.After the replacement, the physician noticed that the electronic tool kit seemed to be heated.Therefore, it was replaced with another electronic tool kit.The product was found acceptable prior to clinical use.There was no adverse consequence to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d10, g4, g7,h2, h3, h6, h10 unique device identifier (udi) : 10886704081272 the certas plus electronic tool kit was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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 or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g1, g3, g6, h2, h3, h6, h11.The certas plus tool kit (id 828852) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the certas plus electronic tool kit was inspected.Fresh batteries were installed.When powered on the led screen illuminated but the device to not fully enter a usable state.After 5 minutes, the device was inspected for excess heat, but nothing usually was sensed.The complaint was not confirmed.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The potential root cause panel ic creates excessive heat during operation or backlight leds creates excessive heat during operation.

• Brand Name: CERTAS PLUS ELECTRONIC TOOL KIT
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10847954
• Report Number: 3013886523-2020-00200
• Device Sequence Number: 3045921
• Product Code: JXG
• UDI-Device Identifier: 10886704081272
• UDI-Public: 10886704081272
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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
• Device Lot Number: 8061230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 11/03/2025
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/10/2020; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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