MAUDE Adverse Event Report: BK MEDICAL APS ENDOCAVITY BIPLANE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 8848

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

Patient was prepped and draped, and procedure started when the brachytherapy probe was noted showing no image on ultrasound machine after repeated attempts by room staff and charge personnel and biomed to troubleshoot unsuccessfully. Procedure was aborted. Note, second case of the day that was cancelled. This submission is similar to report # (b)(4).

• Brand Name: ENDOCAVITY BIPLANE TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS; 8 centennial dr; peabody MA 01960
• MDR Report Key: 10958288
• Report Number: 10958288
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8848
• Device Catalogue Number: 8848
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 0 DA
• Patient Weight: 0