SOLID STATE ELECTROSURGERY SSE-2L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-16 for SOLID STATE ELECTROSURGERY SSE-2L manufactured by Valleylab.

Event Text Entries

[1006] This 78 year old woman underwent colonoscopy, at which time three polyps were removed using the "hot biopsy" forcep and standard electrocautery technique. No immediate problems developed. Eleven days later the patient developed hematochezia and was readmitted for management and required blood transfusion. Repeat colonoscopy failed to reveal a specific bleeding site because a large amount of blood obscurred the view. The bleeding was presumed to come from a polypectomy site. The patient's bleeding stopped spontaneously without further problemsdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved:. Device serviced in accordance with service schedule. Date last serviced: 01-sep-91. 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: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, user education provided, inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2961
• MDR Report Key: 2961
• Date Received: 1992-07-16
• Date of Report: 1992-06-16
• Date of Event: 1992-05-27
• Date Facility Aware: 1992-06-09
• Report Date: 1992-06-16
• Date Reported to Mfgr: 1992-06-16
• Date Added to Maude: 1993-04-02
• 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: SOLID STATE ELECTROSURGERY
• Generic Name: ELECTROSURGICAL GENERATOR
• Product Code: FAR
• Date Received: 1992-07-16
• Model Number: SSE-2L
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2774
• Manufacturer: VALLEYLAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-16