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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN VPV PROGRAMMER REVISED; VPV SYSTEM Back to Search Results
Catalog Number 823192R
Device Problem Excessive Heating (4030)
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 a vpv programmer wasn¿t receiving confirmations and it was overheating after using multiple times.No patient injury reported and it is unknown if the event led to surgical delay.
 
Manufacturer Narrative
The codman programmer (id 823192r) was returned for evaluation.Device history record (dhr): the product 823192r for serial number (b)(6) (lot # 4042694), and the lot met specifications when released failure analysis: the inspection in integra usa has no reported error message issue.Device has been reset, checked and returned to customer.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 a technical problem of the system or to programmer/transmitter malfunction, valve malfunction.
 
Event Description
N/a.
 
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Brand Name
CODMAN VPV PROGRAMMER REVISED
Type of Device
VPV SYSTEM
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 Key12512803
MDR Text Key272694084
Report Number3013886523-2021-00401
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K061876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/15/2022
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
Device Operator Health Professional
Device Catalogue Number823192R
Device Lot Number4042694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received09/22/2021
Supplement Dates Manufacturer Received01/28/2022
Supplement Dates FDA Received02/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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