MAUDE Adverse Event Report: CIVCO MEDICAL INSTRUMENTS CO. INC. TRANSDUCER COVER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number A086368

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

Patient in surgery for right localized partial mastectomy.A civco civ-flex transducer cover was in use.Two orange colored elastic bands on cover broke intraoperatively.All pieces recovered.No patient harm.Fda safety report id # (b)(4).

• Brand Name: TRANSDUCER COVER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): CIVCO MEDICAL INSTRUMENTS CO. INC.
• MDR Report Key: 9451065
• MDR Text Key: 170664319
• Report Number: MW5091562
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2019
• Device Lot Number: A086368
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 77