FDA Adverse Event
Malfunction
Summary report: N
RING & TANDEM COMBINATION APPLICATOR SET
MDR report key: 2494449
·
Received March 13, 2012
Report
- Report Number
- 9612638-2012-00002
- Event Type
- Malfunction
- Date Received
- March 13, 2012
- Date of Event
- February 13, 2012
- Report Date
- March 13, 2012
- Manufacturer
- VARIAN MEDICAL SYSTEMS, INC
- Product Code
- JAQ
- PMA / PMN Number
- K952913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A F/U OF THIS MDR IS EXPECTED AND WILL BE SUBMITTED AS SOON AS THE PART IS RECEIVED AND INVESTIGATED.
Description of Event or Problem · 1
CUSTOMER HAS NOTICED THAT THE RECTAL RETRACTOR (AL07368000) FROM THE RING & TANDEM COMBINATION APPLICATOR SET (AL13017000) IS STARTING TO HAVE THE TITANIUM ROD ALMOST COMING THROUGH. THIS SET HAS BEEN USED AND STERILIZED 16 TIMES TO DATE. NO PT INVOLVEMENT REPORTED. THE PROBLEM WAS IDENTIFIED BY THE USER PRIOR TO FURTHER CLINICAL USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RING & TANDEM COMBINATION APPLICATOR SET | BRACHYTHERAPY APPLICATOR | JAQ | VARIAN MEDICAL SYSTEMS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |