SSE3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-27 for SSE3 manufactured by Valley Lab.

Event Text Entries

[173] Patient admitted to g. I. Lab for colonoscopic exam due to change in bowel habits. This procedure went as planned without complication. Patient was re-admitted the next day with severe abdominal pain. It was determined that there were two left colon burns. Patient was placed on antibotics & observed & recovered. Equipment and other similar indicators were not accurate, thus, causing this burn;unknown to physcian who assumed indicators to be accurate. This has been address by bio-meddevice 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-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, electrical tests performed, mechanical tests performed, performance tests performed. Results of evaluation: design, telemetry failure, none or unknown, power supply. Conclusion: device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device temporarily removed from service, use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 355
• MDR Report Key: 355
• Date Received: 1992-03-27
• Date of Report: 1992-03-18
• Date of Event: 1992-03-06
• Date Facility Aware: 1992-03-06
• Report Date: 1992-03-18
• Date Reported to FDA: 1992-03-18
• Date Reported to Mfgr: 1992-03-18
• Date Added to Maude: 1992-04-20
• 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: ESU-ELECTRO SURGERY UNIT
• Product Code: HAM
• Date Received: 1992-03-27
• Model Number: SSE3
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 353
• Manufacturer: VALLEY LAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-27