MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR KIT W/ SKULL BOLT; ICP MICROSENSORS

Model Number	826638
Medical Device Problem Code	High Readings (2459)
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 a microsensor showed abnormal high reading after zeroing.The procedure was completed with a replacement product available.No patient contact/injury and the event led to around half an hour surgical delay.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The microsensor kit (id 826638) was returned for evaluation.Failure analysis - the issue of the complaint was not confirmed.No visible damage to the millar sensor, catheter material, or connector.Icp express passed with reading 484.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to incorrect set-up of device.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13357793
• Report Number: 3013886523-2022-00016
• Device Sequence Number: 4646389
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: 10381780520504
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• 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): 04/14/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 826638
• Device Catalogue Number: 826638
• Device Lot Number: 5341722
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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