ASPEN LAB INC. MF 360P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-06 for ASPEN LAB INC. MF 360P manufactured by Conmed/aspen Lab Inc..

Event Text Entries

[17806526] Surgical patient accidentally incurred a deep burn on the underside of chin during surgery. Two bovie instruments plugged into the same bovie were being used by the surgeon. One instrument was being used in the wound and the other was laying on the patient's chest. When the foot pedal was activated, both instruments were also activated resulting in the patient's burn. The burn wound was excised and closed. 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-may-92. Service provided by: independent service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: design - inadequate. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3630
• MDR Report Key: 3630
• Date Received: 1992-08-06
• Date of Report: 1992-05-29
• Date of Event: 1992-05-15
• Date Facility Aware: 1992-05-15
• Report Date: 1992-05-29
• Date Reported to Mfgr: 1992-05-29
• Date Added to Maude: 1993-04-28
• 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: ASPEN LAB INC.
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1992-08-06
• Model Number: MF 360P
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-84
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3376
• Manufacturer: CONMED/ASPEN LAB INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-08-06