ESU - ELECTRO - SURGICAL UNIT (CAUTERY) MF 380

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-24 for ESU - ELECTRO - SURGICAL UNIT (CAUTERY) MF 380 manufactured by Aspens Labs/zimmer.

Event Text Entries

[2067] Patient was taken to surgery, chest and neck area prepped with dura prep solution. Cautery was used by md, fire noted, drapes removed, ptient suffered 1 st and 2 nd degree burns on his chest and neck area. 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-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, electrical tests performed, performance tests performed. Results of evaluation: telemetry failure, unanticipated adverse reaction - short term. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3093
• MDR Report Key: 3093
• Date Received: 1992-07-24
• Date of Report: 1992-06-02
• Date of Event: 1992-05-29
• Date Facility Aware: 1992-05-29
• Report Date: 1992-06-02
• Date Reported to Mfgr: 1992-06-02
• Date Added to Maude: 1993-04-08
• 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: ESU - ELECTRO - SURGICAL UNIT (CAUTERY)
• Product Code: IFF
• Date Received: 1992-07-24
• Model Number: MF 380
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2894
• Manufacturer: ASPENS LABS/ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-24