OMNITRON 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-08 for OMNITRON 2000 manufactured by Omnitron.

Event Text Entries

[4485] Omnitron hdr machine was used for brachtherapy to recurrenet anal canal cancer. Source wire broke leaving a four (4) curie iridium 192 source in catheter implanted into tumor. The accident was unrecognized, and source remained in patient 3-1/2 days, delivering a very large radiation exposure to the patient, probably contributing to her deathdevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: component failure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6288
• MDR Report Key: 6288
• Date Received: 1992-12-08
• Date of Report: 1992-12-04
• Date of Event: 1992-11-21
• Date Facility Aware: 1992-12-01
• Report Date: 1992-12-04
• Date Reported to FDA: 1992-12-04
• Date Reported to Mfgr: 1992-12-01
• Date Added to Maude: 1993-08-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OMNITRON 2000
• Generic Name: HIGH DOSE RATE AFTERLOADER OF IRIDIUM 192-SOURCE
• Product Code: IWA
• Date Received: 1992-12-08
• Model Number: 2000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-FEB-92
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 5977
• Manufacturer: OMNITRON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-12-08