MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-12-20 for FLETCHER-SUITE DELCLOS STYLE APPLICATOR SET AL13122005 manufactured by Varian Medical Systems, Inc..
[17260118]
The customer reported that since (b)(6) 2010, inappropriate doses have been delivered to patients receiving gyn intra-cavitary radiation therapy using the al13122005-fletcher-suit delclos style applicator set in conjunction with the al13123000-fsd type gyn coupling catheter set. The distance of the distal end of the colpostat and proximal end of the transfer coupling tube had not been measured correctly with the measurement wire. The radiation source was therefore misplaced and the target organs were missed. The number of pts affected is unk at this time.
Patient Sequence No: 1, Text Type: D, B5
[17553859]
This issue remains under investigation. Additional info has been requested from the customer. This report is based on info received from a third party or developed by varian medical systems. By submitting this report the company is not admitting that the product identified has malfunctions, is defective, or has caused or contributed to a serious injury or death. Info provided in this report is based on the assumption that the info currently available is true and accurate. A follow-up report will be filed once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612638-2013-00018 |
| MDR Report Key | 3541743 |
| Report Source | 01,05,06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-11-27 |
| Date Mfgr Received | 2013-11-27 |
| Date Added to Maude | 2014-01-15 |
| 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, DIRECTOR |
| 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 UK LTD |
| Manufacturer City | CRAWLEY WEST SUSSEX |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLETCHER-SUITE DELCLOS STYLE APPLICATOR SET |
| Generic Name | INTRACAVITARY BRACHYTHERAPY APPLICATOR |
| Product Code | JAQ |
| Date Received | 2013-12-20 |
| Catalog Number | AL13122005 |
| ID Number | AL13123000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-12-20 |