VALLEY LAB SSE21 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-17 for VALLEY LAB SSE21 UNKNOWN manufactured by Valley Lab, Inc..

Event Text Entries

[2696] During cystoscopic procedure, surgeon reported the coagulation on bovie was not working (no power) and he requested that the power be increased. Power was increased to 3-4 on dial with no improvement. Dial increased to 5 and surgeon finished procedure. He reported he saw a spark flash which was resulted in a perforation of the bladder. Bovie unit was replaced with different machinedevice not labeled for single use. 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-dec-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, electrical tests performed, performance tests performed, visual examination. Results of evaluation: telemetry failure, other. Conclusion: device was out of spec in a manner that relates to event, device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5020
• MDR Report Key: 5020
• Date Received: 1993-06-17
• Date of Report: 1993-06-02
• Date of Event: 1993-05-26
• Date Facility Aware: 1993-05-26
• Report Date: 1993-06-02
• Date Reported to Mfgr: 1993-06-01
• Date Added to Maude: 1993-06-22
• 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: VALLEY LAB
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1993-06-17
• Model Number: SSE21
• Catalog Number: UNKNOWN
• ID Number: NIH PROPERTY #942901
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-NOV-83
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4723
• Manufacturer: VALLEY LAB, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-17