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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROTEK MEDICAL B.V. VARSSEVELD MICROTEK INTRAOPERATIVE PROBE COVER; TRANSDUCER, ULTRASONIC

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MICROTEK MEDICAL B.V. VARSSEVELD MICROTEK INTRAOPERATIVE PROBE COVER; TRANSDUCER, ULTRASONIC Back to Search Results
Catalog Number PC1292
Patient Problem Insufficient Information (4580)
Event Date 07/13/2023
Event Type  Injury  
Event Description
After the sentinel node portion of the surgery was complete, the c-track probe was handed off of the field.When i removed the probe cover, it was discovered that the probe had blood on it and the inside of the cover was also bloody.Although i couldn't see a hole, it was obviously leaking.The wound class was changed to "contaminated" and the operating room clinician and surgeon were informed of the incident.
 
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Brand Name
MICROTEK INTRAOPERATIVE PROBE COVER
Type of Device
TRANSDUCER, ULTRASONIC
Manufacturer (Section D)
MICROTEK MEDICAL B.V. VARSSEVELD
MDR Report Key17371673
MDR Text Key319570059
Report NumberMW5119774
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/14/2023
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 Catalogue NumberPC1292
Device Lot Number5093LA0900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/19/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age89 YR
Patient SexFemale
Patient RaceWhite
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