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

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.

• Brand Name: IP57 ULTRASOUND PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS; albert c. cefalo; 8 centennial dr; peabody MA 01960
• MDR Report Key: 6976121
• MDR Text Key: 90190681
• Report Number: 6976121
• 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: User Facility
• Reporter Occupation: Other
• 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 Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8826
• Device Catalogue Number: 8826
• Other Device ID Number: MILLIPARKEN 34 DK-2730 HERLEV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 58 YR
• Patient Weight: 91