MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN VPV PROGRAMMER REVISED; VPV SYSTEM

Model Number	823192R
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
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: when the surgeon tried to program the valve, programmer began to make smog from behind.Smell of smog coming from the machine.It was impossible to know if the valve was properly regulated; therefore, patient had a x-ray exam to check the proper level of valve regulation.Product was in contact with the patient; however, no patient injury reported and the event did not led to surgical delay.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The programmer was returned for evaluation: dhr - the lot met specifications when released.Failure analysis - the machine was kept on for 3 hours, and no burning smell came out of it.The coil of the power module was loosened.As a preventive measure, the power module will be replaced.Root cause - the root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause for this issue reported by the customer could be due to failure of transformer, unit shutdown by secondary means or to a technical problem of the system.
Event or Problem Description
N/a.

• Brand Name: CODMAN VPV PROGRAMMER REVISED
• Common Device Name: VPV SYSTEM
• 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: 15244099
• Report Number: 3013886523-2022-00382
• Device Sequence Number: 6293080
• Product Code: JXG
• UDI-Device Identifier: 10886704078609
• UDI-Public: 10886704078609
• Combination Product (Y/N): N
• PMA/510(K) Number: K061876
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 Model Number: 823192R
• Device Catalogue Number: 823192R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2018
• 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