FDA Adverse Event
Malfunction
Summary report: N
CANNULA SMOOTH FLEX 6.5 X 72MM
MDR report key: 6123630
·
Received November 23, 2016
Report
- Report Number
- 1219602-2016-01278
- Event Type
- Malfunction
- Date Received
- November 23, 2016
- Date of Event
- October 24, 2016
- Report Date
- October 25, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- NBH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE CLINICAL DETAILS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT FRAGMENTS OF THE CANNULA BROKE IN THE PATIENT. THE PIECES WERE REMOVED USING A GRASPHER AND SHAVER SUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776769 | CANNULA SMOOTH FLEX 6.5 X 72MM | ACCESSORIES, ARTHROSCOPIC | NBH | SMITH & NEPHEW, INC. | 428160624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |