MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-31 for FLETCHER-SUIT-DELCOS-STYLE APPLICATOR SET AL13030001 manufactured by Varian Medical Systems, Inc..
[4131593]
The customer reported that they treated a patient using the al13030001-fletcher-suit-delcos-style applicator with the al07344000-titanium cervical stop. The customer stated that this patient experienced an ulceration at the location of the cervical stop. This is the third incident reported. Details on other 2 incidents filed under mfr report #9612638-2013-00012 and 9612638-2013-00013.
Patient Sequence No: 1, Text Type: D, B5
[11643378]
No sharp edges were found through the visual and haptic inspection of the returned al07344000 titanium cervical stop. Two cervical stoppers from stock, manufactured in 2009, were inspected and no sharp edges were noticed. This suggests that the current issue, reported in varian complaint (b)(4), is not related to a change in the manufacturing processes. The related drawings of the suspect part were reviewed. From a design standpoint, the titanium cervical stop does not indicate that there is a risk of scratching a patient to bleeding. The set screw has a length that ensures that it is not protruding out of the cervix marker if tightened correctly to the tandem. The customer's allegation was not able to be confirmed. The root cause of the issue is unknown. The device did not malfunction. No further f/u to this report is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612638-2014-00001 |
| MDR Report Key | 3621486 |
| Report Source | 05,06 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-03 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-01-03 |
| Date Added to Maude | 2014-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK KATTMANN |
| Manufacturer Street | 700 HARRIS STREET, SUITE 109 |
| Manufacturer City | CHARLOTTESVILLE VA 22903 |
| Manufacturer Country | US |
| Manufacturer Postal | 22903 |
| Manufacturer Phone | 4349518632 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS HAAN GMBH |
| Manufacturer Street | BERGISCHE STRASSE 16 |
| Manufacturer City | HAAN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLETCHER-SUIT-DELCOS-STYLE APPLICATOR SET |
| Generic Name | INTRACAVITARY BRACHYTHERAPY APPLICATOR |
| Product Code | JAQ |
| Date Received | 2014-01-31 |
| Returned To Mfg | 2014-01-06 |
| Catalog Number | AL13030001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3100 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-31 |