HOOK ELECTRODE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-31 for HOOK ELECTRODE manufactured by Cabot Medical.

Event Text Entries

[16783197] During surgical procedure the physician indicated that he had "been burned" with a hook electrode (unipolar). Glove was noted to have a hole and was changed. At the end of the procedure the patient was checked and it was noted that the patient's skin was intact except the skin edges on the 2nd and 3rd trocar sites, which were redish brown. Physician noted areas on thumb and index finger. No patient/physcian medical treatment requireddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: insulation degradation/deterioration, mated with incompatible equipment, misapplication of device. Conclusion: intermittent failure directly contributed to event, device evaluated and alleged failure could not be duplicated, no failure detected and product within specification. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor, device temporarily removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 167
• MDR Report Key: 167
• Date Received: 1992-01-31
• Date of Report: 1992-01-23
• Date of Event: 1992-01-09
• Date Facility Aware: 1992-01-09
• Report Date: 1992-01-23
• Date Reported to FDA: 1992-01-23
• Date Reported to Mfgr: 1992-01-17
• Date Added to Maude: 1992-04-02
• 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: HOOK ELECTRODE
• Product Code: HAM
• Date Received: 1992-01-31
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 164
• Manufacturer: CABOT MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-01-31