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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: patient in room at 9:48 am.Patient out of room at 10:23 am.Patient approximately 5 years 10 months old; patient weight 18.9 kg.Surgeon: dr.(b)(6).Patient¿s parents noticed spot after surgery on patient¿s lower back.What was the surgical procedure? tube removal, gelfilm patch, tonsilectomy and adenoidectomy.Was there anything between patient? 2 sheets (draw sheet and another sheet that has an absorbable pad).This is the same setup the facility has been using since implementation of megasoft 2.5 years ago.What generator was being used? covidien force fx.The cleaning of the pads with sani wipes and then no rinsing but letting them dry.Biomed did not report any physical damage to the pad.With the 5-year-old patient that was weighing 15.9kg with serial number (b)(4).This patient went home and the mom reported 3 days later with a red size of triangle burn and blistered.Then another spot showed up later.It was painful for the child.The child was seen by the dermatologist and was seen at the burn clinic.The child also having a fever of 103 and constipation.Wound care was brought in, and treatment was provided and then the child was sent home.The patient was supine with a shoulder roll.Absorbable drape over the table.The pad was on the entire back of the child.No decrease of power of generator.Or nurse did not notice any burns after the procedure and did not report any.Standard surgical table.No bear hugger no warming blankets used.No metal on child no implants.Patient had disposable shorts that had elastic on the waistband.No urine or fluids around site.The account was told about the burns on the 20th.The mom called on the 19th and said the child had burns on the back.Burn is 2nd degree located gluteal cliff.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.If no, why not? answer: no, it is pending pick-up from representative for quality assurance testing.What is the severity of the burn? (please see degrees of burns below and choose one) second degree first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful second degree burn: 1.5x0.5cm and located at the top of the gluteal cleft.Third degree burn the burn site looks deep, whitening or blackened and charred third degree burn the burn site looks deep, whitening or blackened and charred what medical intervention was used to treat the burn? (such as salve or stitches) there was no known indication of a burn after procedure; mother reported burn post-op, burn was evaluated in emergency department postop.Applications as needed of bacitracin; follow-up in burn clinic.Could the skin condition actually be the result of another illness of the patient? besides the burn, did the patient experience any adverse consequence due to the issue? no are there any anticipated long-term effects from the burn or injury? no.What is the current status of the patient? patient had constipation, dehydration, and 103 degree fever post-op.Clinician advised mother to go to emergency department.After ed evaluation, patient follow-up is to burn clinic.What was the surgical procedure? tube removal with gelfilm patch an a tonsillectomy and adenoidectomy.How was the patient positioned? supine with arms tucked by side with a shoulder roll how was the room set up to include patient set up and where was the pad in relation to the patient? megadyne pad was on the or table with the patient on top of the pad.Was there anything between patient? the disposable pad and disposable sheet/shorts were between the pad and patient.Both of these items are available for qa testing with the pad.Was the pad rinsed and let dry before it on this surgical procedure? yes, with the disposable wipes so the pad could be sanitized.How was pad cleaned? wiped down with super sani-cloth germicidal disposable wipes and let dry does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? to be qa evaluated by manufacturer.There was no indication of a burn on the day after procedure.Was there any patient warming blankets used? no.If yes what warming blankets were used? what brand of warming blanket was used? is it possible the patient was in contact with a metal portion of the operating room table? no.What generator was being used? esu 1-16-67 covidian force fx.What power levels was generator set to? 15-40.What was the end factor that was being used? unknown.Was a warming device used and if so brand and location? no.Were there liquids used in prep? no.Was urine or other fluids detected in the field after surgery? no.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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(b)(4).Date sent: 2/1/2023.Photo analysis: this is an analysis of an image submitted for evaluation.Image: on the photo, there is a burn mark in the central lower back of a kid.The burn shows oval shape with one blister at each side and red rim on top and bottom but middle area does not have apparent injury.The burn is considered second-degree in severity.Of note, there appears also two light skin red rims around lower back.The above burn injury is within the red belt.No conclusion could be reached as to how this issue occurred through photo analysis.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The cables and pad were returned for analysis.Visual analysis of the returned sample revealed that the 0847 pad and cables were returned with no apparent damage.In addition, a blue surgical blanket was returned inside a plastic bag.The pad and cables were connected to the generator and worked as intended.No anomalies were observed with the functionality of the device that could have caused the reported event.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device sn: (b)(6), and no non-conformances were identified.
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