MAUDE Adverse Event Report: SHEATHING TECHNOLOGIES, INC. SHEATHES; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 10340

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

During the performance of an endocavital procedure, when technician removed the transducer, it was noticed that the probe cover was at the end of the probe.Transducer broke.

• Brand Name: SHEATHES
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): SHEATHING TECHNOLOGIES, INC.; 675 jarvis drive; morgan hill CA 95037
• MDR Report Key: 10851627
• MDR Text Key: 216607060
• Report Number: 10851627
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10340
• Device Lot Number: 19-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Weight: 109