UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-18 for UNKNOWN manufactured by Unknown.

Event Text Entries

[520] Tip of probe broke off in patient. Retreived under floroscopy with no remnant in patient. The probe is approximately 140 mm. X 2. 13 mm. The break occurred 15. 31 mm. For the distal tip. According to clinical engineering, the probable cause for the break is that the metal becomes brittle with repeated sterilization, and breaks when pressure is appliedinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: end of life - expected. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1123
• MDR Report Key: 1123
• Date Received: 1992-08-18
• Date of Report: 1992-07-27
• Date of Event: 1992-06-16
• Date Facility Aware: 1992-06-16
• Report Date: 1992-07-27
• Date Reported to FDA: 1992-07-27
• Date Reported to Mfgr: 1992-07-27
• Date Added to Maude: 1992-08-25
• 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

• Generic Name: PROBE
• Product Code: HXB
• Date Received: 1992-08-18
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1076
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-18