FDA Adverse Event
Malfunction
Summary report: N
SYNOVATOR BLADE, 4.5 DISP, EP-1
MDR report key: 1350847
·
Received January 21, 2009
Report
- Report Number
- 1219602-2009-00012
- Event Type
- Malfunction
- Date Received
- January 21, 2009
- Report Date
- December 22, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- HRX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
BLADE SHEDDING AND A LEAKING GOO SUBSTANCE FROM THE BLADE WAS LEFT IN THE PT'S JOINT. THE SURGEON WAS PLANNING TO PERFORM ANOTHER PROCEDURE WHEN REALIZING THESE SUBSTANCES WERE LEFT IN THE JOINT AFTER TAKING AN MRI. A SECOND SURGERY WAS THEN PERFORMED TO FLUSH OUT THE JOINT. AN ADDITIONAL MRI IS SCHEDULED TO DETERMINE IF THE JOINT IS CLEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNOVATOR BLADE, 4.5 DISP, EP-1 | SYNOVATOR BLADE | HRX | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 7205310 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |