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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BK MEDICAL APS IP57 ULTRASOUND PROBE TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BK MEDICAL APS IP57 ULTRASOUND PROBE TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 8826
Device Problems Component Falling (1105); Crack (1135); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2017
Event Type  malfunction  
Event Description
During the procedure, the rubber seal fracture on the ultrasound device cracked and fell into the surgical site. The black pieces were retrieved. The vendor was notified regarding event and equipment.
 
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Brand NameIP57 ULTRASOUND PROBE
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BK MEDICAL APS
albert c. cefalo
8 centennial dr
peabody MA 01960
MDR Report Key6976121
MDR Text Key90190681
Report Number6976121
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8826
Device Catalogue Number8826
Other Device ID NumberMILLIPARKEN 34 DK-2730 HERLEV
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2017
Event Location Hospital
Date Report to Manufacturer09/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/25/2017 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
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