UROLOGICAL X-RAY TABLE HYDRAJUST II N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-23 for UROLOGICAL X-RAY TABLE HYDRAJUST II N/A manufactured by Liebel Flarsheim.

Event Text Entries

[2001] Patient under general anesthesia for insertion of double-j stent into right ureter through cystoscope, under flouroscopy with video camera. Table would not move side to side or up and down, and bucky would not move when needed. X-ray done when patient was in post anesthesia recovery room revealed perforated right ureter. Patient was taken back to the cysto room and stent was removed under local anesthetic. Right nephrostomy tube was inserted under i. V. Anesthesia in radiology department. Screw in foot pedal was loose, causing motor to run continually, which caused circuit breaker to trip. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-92. Service provided by: user facility biomedical/bioengineering department. 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, performance tests performed. Results of evaluation: other. Conclusion: device failure occurred but not related to event. Certainty of device as cause of or contributor to event: no. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4055
• MDR Report Key: 4055
• Date Received: 1992-07-23
• Date of Report: 1992-05-15
• Date of Event: 1992-05-09
• Date Facility Aware: 1992-05-09
• Report Date: 1992-05-15
• Date Reported to Mfgr: 1992-05-15
• Date Added to Maude: 1993-05-13
• 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: UROLOGICAL X-RAY TABLE
• Generic Name: CYSTO TABLE
• Product Code: EYH
• Date Received: 1992-07-23
• Model Number: HYDRAJUST II
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 1083
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3788
• Manufacturer: LIEBEL FLARSHEIM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-23