FDA Adverse Event
Other
Summary report: N
THE SPIDER
MDR report key: 2823919
·
Received August 6, 2010
Report
- Report Number
- 9681741-2010-00001
- Event Type
- Other
- Date Received
- August 6, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 26, 2010
- Manufacturer
- TENET MEDICAL ENGINEERING
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
TENET HAS NOT HAD AN OPPORTUNITY TO INSPECT THE PRODUCT FOR DAMAGE THAT MAY HAVE CAUSED A MALFUNCTION. IT IS SUSPECTED THAT THE USER DID NOT CORRECTLY ENGAGE AND THEN LOCK THE QUICK CONNECT BEFORE BEGINNING SURGERY, AS OUTLINED IN NUMEROUS LOCATIONS IN IFU'S SUPPLIED WITH THE PRODUCT AND IT'S ACCESSORIES. THE LOCAL DISTRIBUTION REPRESENTATIVE WILL BE CONTACTED TO VIEW THE PRODUCT AND INSPECT FOR DAMAGE.
Description of Event or Problem · 1
USER DESCRIBES DISCONNECTION OF SPIDER LIMB POSITIONER FROM PATIENT DURING PROCEDURE, ALLOWING THE POSITIONER OR PATIENT'S ARM (NOT CLEAR) TO DROP, CONTAMINATING THE STERILE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE SPIDER | SPIDER ARM | FWZ | TENET MEDICAL ENGINEERING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |