ELECTROSURGICAL COAG/SUCTION TUBE 809600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-11 for ELECTROSURGICAL COAG/SUCTION TUBE 809600 manufactured by Weck & Company.

Event Text Entries

[5346] On 2/18/93, during a tonsil and adenoid operation on a 13 year old female patient, the surgeon reported a flash when using an electrosurgical unit. The patient sustained a burn on the inner right aspect of her mouth. The actural product had been discarded, but the manufacturer was notified of the incident. They evaluated a sample from the same lot and found it to be within manufacturer specifications. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9365
• MDR Report Key: 9365
• Date Received: 1993-08-11
• Date of Report: 1993-07-29
• Date of Event: 1993-02-18
• Report Date: 1993-07-29
• Date Added to Maude: 1994-12-12
• 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: ELECTROSURGICAL COAG/SUCTION TUBE
• Product Code: KCB
• Date Received: 1993-08-11
• Catalog Number: 809600
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9022
• Manufacturer: WECK & COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-08-11