CONCEPT 9900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-19 for CONCEPT 9900 manufactured by Concept Incorporated.

Event Text Entries

[15376653] During a surgical procedure, the patient sustained a small burn to her shoulder because the grounding pad used with the concept cautery unit became partially dislodged from the patient. After the incident, the concept unit was checked thoroughly by our biomedical engineering department and was found to be in perfect working order. As a result of this incident, we decided to purchase cautery equipment which is equipped with an alarm system which is triggered in the event that a grounding pad inadvertently becomes dislodged. As of this date, we have replaced all concept units. There was no equipment failure involved in this incident. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-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: telemetry failure. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4460
• MDR Report Key: 4460
• Date Received: 1992-08-19
• Date of Report: 1992-07-30
• Date of Event: 1992-03-11
• Date Facility Aware: 1992-03-11
• Report Date: 1992-07-30
• Date Reported to FDA: 1992-07-30
• Date Reported to Mfgr: 1992-07-29
• Date Added to Maude: 1993-05-25
• 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: CONCEPT
• Generic Name: ELECTROSURGICAL GENERATOR
• Product Code: HQQ
• Date Received: 1992-08-19
• Model Number: 9900
• Catalog Number: 9900
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JAN-85
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4181
• Manufacturer: CONCEPT INCORPORATED

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-08-19