FDA Adverse Event
Other
Summary report: N
ICT / 8-5MHZ TRANSDUCER
MDR report key: 2177020
·
Received October 13, 2008
Report
- Report Number
- 3032367-2008-00006
- Event Type
- Other
- Date Received
- October 13, 2008
- Date of Event
- August 28, 2008
- Report Date
- September 25, 2008
- Manufacturer
- SONOSITE, INC.
- Product Code
- ITX
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS THERE WAS NO MALFUNCTION, WE INVESTIGATED THROUGH INTERVIEW. THE DEVICE WAS OPERATING TO SPECIFICATION. THE CUSTOMER'S TRANSDUCER WAS REPLACED WITH A C8 TRANSDUCER WHICH IS DESIGNED SPECIFICALLY FOR TRANS RECTAL PROCEDURE.
Description of Event or Problem · 1
OUR CUSTOMER CALLED STATING THAT WHEN USING AN ICT TRANSDUCER AND BIOPSY GUIDE TO PERFORM A TRANS-RECTAL BIOPSY PROCEDURE, PATIENTS EXPERIENCED EXCESSIVE BLEEDING. THE COMPLAINT WAS NOT SPECIFIC TO ONE PATIENT. THE USER STATED IN GENERAL THE EXCESSIVE BLEEDING OCCURRED. NO INTERVENTION WAS REQUIRED. SONOSITE, INC IS THE MANUFACTURER OF THE ICT TRANSDUCER. SONOSITE DOES NOT MANUFACTURE BIOPSY GUIDES WHICH MAY BE USED WITH THE TRANSDUCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICT / 8-5MHZ TRANSDUCER | ICT TRANSDUCER | ITX | SONOSITE, INC. | P04538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CIVCO DISPOSABLE ENDOCAVITY NEEDLE GUIDE |