VALLEYLAB SSE4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for VALLEYLAB SSE4 manufactured by Valleylab.

Event Text Entries

[16401484] Electro surgical cautery unit allegedly malfunctioned during a tur-p procedure. Uterine orifice was fulgerated when cautery unit continued to cauterize after the physician removed his foot from the foot pedal. The physician had to insert a right ureteral catheter into the patient's right ureter. This procedure would not have been done otherwise. Our bio-medical department checked the foot pedal of the machine and found it to be functioning properly. They could not duplicate the occurrence. Device 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-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. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3371
• MDR Report Key: 3371
• Date Received: 1992-07-22
• Date of Report: 1992-05-11
• Date of Event: 1992-05-01
• Date Facility Aware: 1992-05-01
• Report Date: 1992-05-11
• Date Reported to Mfgr: 1992-05-06
• Date Added to Maude: 1993-04-16
• 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: VALLEYLAB
• Generic Name: ESU - ELECTRO SURGICAL UNIT
• Product Code: FAR
• Date Received: 1992-07-22
• Model Number: SSE4
• Catalog Number: SSE4
• ID Number: 003903
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3143
• Manufacturer: VALLEYLAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-22