MAUDE Adverse Event Report: FIAB SPA HTC - HIGH TEMPERATURE CAUTERY; STERILE SINGLE USE ELECTROCAUTERY, BATTERY OPERATED

Model Number F7244

Device Problem Flare or Flash (2942)

Patient Problem Eye Burn (2523)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information currently available, the occurrence of the incident can be traced to an improper use / use of the device in spite of the warnings contained in the ifu.The activation of the cautery is in fact - through its incandescent tip filament (1200°c) - a source of ignition and therefore it must be strictly avoided to use the device in presence of flammable substances such as disinfectants, anesthetic mixtures, oxygen.The use of oxygen in the proximity of the operation area has been referred and therefore it can be assumed as the likely cause of the flame in the presence of cautery activation.Further investigations will be conducted on the sample of the device, as soon as it is available, to assess whether or not it corresponds to the design and construction specifications, and any defects involving failure modes alternative to the one assumed.A follow-up report with the results of this technical investigation and the outcome of the overall evaluation will be sent.The information required in the following sections were not provided since not available in the information from the initial reporter (patient name), (birth date), (patient weight), (patient ethnicity), (patient race) (relevant test / laboratory data), (other relevant history).(lot nr / expiry date) - this has been requested to distributor.(manufacturing date) - to be provided after lot nr became available.(type of investigation.Investigation findings.Investigation conclusions) - to be included in the followup report.

Event Description

Indication for surgery: removal of a recurrent cutaneopalpebral lesion located in the left internal corner, under general anesthesia with spontaneous ventilation and placement of o2 nasal cannula.The nasal region was covered with a surgical mask and then with a surgical drape and an ophthalmological drape leaving only the left orbital region uncovered.At the end of the operation, during the cauterization of the surgical area with the cautery, a flame suddenly formed, burning the eyelashes at the level of the upper and lower eyelid (palpebral slit closed).Flame was extinguished by the physician.A second degree burn partially affected the skin of the upper eyelid.The eyelashes were burnt.At the opening of the eyelid, a central burn, from limbus to limbus was noted on the cornea.Initial treatment with saline solution washing of the necrotic and bleached corneal epithelium showing a clear and transparent underlying stroma.Treatment then included application of antibiotic eye ointment combined with an eye patch and systemic pain relievers.Hospitalization of 48 hours was necessary for treatment with local ointments every hour and monitoring of healing.Visual acuity was calculated the next morning at 4/10 without correction and at 7/10 the following day.Corneal epithelial healing was complete on the 3rd postoperative day.The major upper palpebral edema is clearly decreasing each day with a possible spontaneous opening of the palpebral cleft on the 3rd postoperative day, making visible the base of the burnt eyelashes above and below.However, there is to date a central infiltration in the persistent stromal pupillary area whose evolution is uncertain: either total disappearance with the current local treatment by corticosteroid therapy or sequel with non recovery of corneal transparency: knowing that the acuity visual control on the 5th postoperative day stagnates at 7/10.No pain referred by the patient.Overall, regular monitoring is set up with local treatment (corticosteroids in eye drops and ointment, lubricating agents in eye drops, petroleum jelly ointment on the upper eyelid) for at least 15 days.

Event Description

Indication for surgery: removal of a recurrent cutaneopalpebral lesion located in the left internal corner, under general anesthesia with spontaneous ventilation and placement of o2 nasal cannula.The nasal region was covered with a surgical mask and then with a surgical drape and an ophthalmological drape leaving only the left orbital region uncovered.At the end of the operation, during the cauterization of the surgical area with the cautery, a flame suddenly formed, burning the eyelashes at the level of the upper and lower eyelid (palpebral slit closed).Flame was extinguished by the physician.A second degree burn partially affected the skin of the upper eyelid.The eyelashes were burnt.At the opening of the eyelid, a central burn, from limbus to limbus was noted on the cornea.Initial treatment with saline solution washing of the necrotic and bleached corneal epithelium showig a clear and transparent underlying stroma.Treatment then included application of antibiotic eye ointment combined with an eye patch and systemic pain relievers.Hospitalization of 48 hours was necessary for treatment with local ointments every hour and monitoring of healing.Visual acuity was calculated the next morning at 4/10 without correction and at 7/10 the following day.Corneal epithelial healing was complete on the 3rd postoperative day.The major upper palpebral edema is clearly decreasing each day with a possible spontaneous opening of the palpebral cleft on the 3rd postoperative day, making visible the base of the burnt eyelashes above and below.However, there is to date a central infiltration in the persistent stromal pupillary area whose evolution is uncertain: either total disappearance with the current local treatment by corticosteroid therapy or sequel with non recovery of corneal transparency: knowing that the acuity visual control on the 5th postoperative day stagnates at 7/10.No pain referred by the patient.Overall, regular monitoring is set up with local treatment (corticosteroids in eye drops and ointment, lubricating agents in eye drops, petroleum jelly ointment on the upper eyelid) for at least 15 days.

Manufacturer Narrative

The information required in the following sections have included in the follow up report since not available at the time of sending the initial report d4 (lot nr) - two lot numbers 4528 or 4354 have been indicated because the distributor sold both to the hospital and the user, after having opened the single sterile package and thrown the tyvek pouch was no longer able to establish the exact lot nr used.

• Brand Name: HTC - HIGH TEMPERATURE CAUTERY
• Type of Device: STERILE SINGLE USE ELECTROCAUTERY, BATTERY OPERATED
• Manufacturer (Section D): FIAB SPA; via costoli 4; vicchio (fi), 50039 ; IT 50039
• MDR Report Key: 11273968
• MDR Text Key: 230120292
• Report Number: 3003072803-2021-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 18033695727142
• UDI-Public: 18033695727142
• Combination Product (y/n): N
• PMA/PMN Number: K100333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F7244
• Device Catalogue Number: F7244
• Device Lot Number: 4528 OR 4354
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NASAL CANNULA FOR OXIGEN-THERAPY; NASAL CANNULA FOR OXIGEN-THERAPY; NASAL CANNULA FOR OXIGEN-THERAPY
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 13 YR