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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION SPENCER PROBE DEPTH ELECTRODE; ELECTRODE, DEPTH
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AD-TECH MEDICAL INSTRUMENT CORPORATION SPENCER PROBE DEPTH ELECTRODE; ELECTRODE, DEPTH Back to Search Results
Model Number SD08R-SP05X-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
The patient was brought back to surgery post op day 3 to have seeg electrodes replaced due to increasing artifact occurring on the eeg tracing.These artifacts started occurring on post op day 1.A total of 8 electrodes were replaced, four 8 contact and four 12 contact electrodes.Specific lot numbers for each electrode were not tracked, but electrodes from the following lots were removed.Lot numbers for the 8 contact electrodes were 0156088807808809, 0156892810811812, 0156947810811812, lot numbers for the 12 contact electrodes were 0155369804805806, 0155859804805806, 0157433810811812, 0159437819820821, 0159595819820821.
 
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Brand Name
SPENCER PROBE DEPTH ELECTRODE
Type of Device
ELECTRODE, DEPTH
Manufacturer (Section D)
AD-TECH MEDICAL INSTRUMENT CORPORATION
400 west oakview parkway
oak creek WI 53154
MDR Report Key16597463
MDR Text Key311847295
Report Number16597463
Device Sequence Number1
Product Code GZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/14/2023
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
Device Operator Health Professional
Device Model NumberSD08R-SP05X-000
Device Catalogue NumberSD08R-SP05X-000
Device Lot Number0156088807808809
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/14/2023
Event Location Hospital
Date Report to Manufacturer03/23/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/23/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age4745 DA
Patient SexFemale
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