MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DIRECTLINK ICP MODULE; DIRECTLINK - MODULE

Model Number	826828
Medical Device Problem Code	Incorrect Measurement (1383)
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
Other mfg report number: 3013886523-2022-00599.A facility reported negative values of a cerelink microsensor (id 826851).The sensor was used with directlink icp module (id 826828).Monitoring was not possible, therefore, sensor was explanted.
Additional Manufacturer Narrative
Directlink module was returned for evaluation: dhr - the lot met specifications when released.Failure analysis - the module was cleaned with isopropyl alcohol 70% and visually inspected: no defect was noted.The module was inspected: no defect was noted.The complaint evaluation was unable to conclusively verify the complaint as valid.Device passed all testing.The root cause of the issue reported by customer could not be determined as the device worked correctly.
Event or Problem Description
N/a.

• Brand Name: DIRECTLINK ICP MODULE
• Common Device Name: DIRECTLINK - MODULE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16158899
• Report Number: 3013886523-2023-00004
• Device Sequence Number: 7052389
• Product Code: GWM
• UDI-Device Identifier: 10381780515784
• UDI-Public: 10381780515784
• Combination Product (Y/N): N
• PMA/510(K) Number: K152670
• 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): 07/12/2023

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 Model Number: 826828
• Device Catalogue Number: 826828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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