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

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.

• Brand Name: MICROTEK INTRAOPERATIVE PROBE COVER
• Type of Device: TRANSDUCER, ULTRASONIC
• Manufacturer (Section D): MICROTEK MEDICAL B.V. VARSSEVELD
• MDR Report Key: 17371673
• MDR Text Key: 319570059
• Report Number: MW5119774
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC1292
• Device Lot Number: 5093LA0900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Race: White