MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK

Catalog Number 826851

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

A facility reported that when resetting the sensor, the orange light flashes after the user presses the 0 button for 8 seconds; after which the light does not stop on green but on orange.They tried changing the direclink module but encountered the same problem; they changed the sensor and it worked.No patient impact; however, the event led to 30 minutes surgical delay.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Type of Device: ICP MICRSOSENSORS - CERELINK
• 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: 18625205
• MDR Text Key: 334532655
• Report Number: 3013886523-2024-00024
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K173192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826851
• Device Lot Number: 6806101
• Date Manufacturer Received: 01/15/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1