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(b)(4).Date sent: 1/4/2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Photo analysis: this is an analysis of an image submitted for evaluation.Two photos of the patient's lower abdomen were submitted for evaluation.A burn wound in the size of a thumb tip can be seen in the middle of the lower abdomen.The burn appears to involve the outer and some middle layers of skin.The central area of the burn is dry and tends to be pale in color.No significant swelling or blistering was observed.Per appearance, it is likely a second-degree burn.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information received: surgeon experience with the device? 6 months ¿ 2 years additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.If no, why not? no, they have pulled the pads due to the incident.Their two pads are sitting in the or managers office.Are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com already attached these to the pc is there any damage(s) noted on the pad? no.If yes, where are they and what is the description of the damage(s)? are there photos that can be shared of the pad? see pc.If yes, please send to productcomplaint1@its.Jnj.Com what is the serial number of the pad? tbd how long has the account been using mega soft? approximately 2 years does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? they are unsure of what happened.I personally think this may be a classic alternate site burn situation due to the metal clamp that was touching the patient and being held by the surgeon.When were the burns first noticed? a few minutes in, surgeon noticed a tingling on their hand which was touching the metal clamp, they then realize a small blister on the patients skin.All of this is in the pc what is the severity of the burn? (please see degrees of burns below and choose one) 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.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)? unknown where is the burn located on the patient? abdomen was the reported issue at the pad site or alternate site? alternate site (by metal clap) this is stated in the pc besides the burn, did the patient experience any adverse consequence due to the issue? not to my knowledge are there any anticipated long-term effects from the burn or injury? unknown what is the current status of the patient? unknown, sounds like the patient was okay what was the surgical procedure? c-section what was the surgical procedure date? check pc how long did the surgical procedure last? unknown what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? an approved cleaner, cavi wipes.Was the pad rinsed with water and let dry before this surgical procedure? yes how was the patient positioned? supine is it possible the patient was in contact with a metal portion of the or table? doubtful but patient had metal clamp on them which was touching the surgeons hand, electricity takes the path of least resistance, which makes me think this could be an alternate site burn how was the room set up to include patient set up and where was the pad in relation to the patient? underneath patient with sheet, and thin soaker pad covering bottom 25% of pad.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? see above were there liquids used in prep? unknown what skin preparation regiment was utilized for the procedure? unknown was urine or other fluids detected in the field after surgery? unknown was there any patient warming blankets used? unknown.If yes, what warming device and/or blankets were used and what is the location in relation to the patient? what temperature setting was used on the warming device(s)? what generator was being used? force fx generator what power levels was generator set to? unknown was there any diminished effect of the generator noted during the surgery?no what monopolar disposables were used during the procedure? unknown what is the age of the patient? unknown if the age of the patient is not known, is the patient an adult or pediatric patient? adult what ethnicity is the patient? unknown attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was the snap a part of the patient¿s gown? if not, what was it a part of? the event description mentions: "the surgeon also ended up with a red mark on her right hand which was directly above where the patient had a burn." the following questions are in regards of the surgeon: are there any photos of the burn (s) that you could share with us in regards to the burn? · if yes, please send to productcomplaint1@its.Jnj.Com when were the burns first noticed? what is the severity of the burn? (please see degrees of burns below and choose one) · 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 · 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)? where is the burn located on the surgeon? was the reported issue at the pad site or alternate site? besides the burn, did the surgeon experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the surgeon? what is the age of the surgeon? what ethnicity is the surgeon? 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: 1/18/2024.Additional information received: during the case the surgeon had the cautery in her left hand and was holding a snap in her right hand.The snap was attached to the patient and her right hand was resting/in contact with the abdomen, where the burn occurred.The surgeon pressed the cautery button to cauterize and felt a burning sensation in her right hand.When she moved her hand the surgeon saw a wound on the patients abdomen, which was not there prior to the incident.The surgeon also ended up with a red mark on her right hand which was directly above where the patient had a burn.Hospital had pulled the megasoft pads from use following this incident.The incident occurred during a c-section while using the universal pad.The incident scared/worried the physician a little bit.The rep talked through what an alternate site burn was with the or manager and allowed her to draw her own hypotheses about that being a possibility.Pads have been in use for about 4 months.The rep indicated that 1 bedsheet was used along with a green soaker sheet on the patient.There is an additional 3rd blue sheet.The rep indicated that the placement of cables would not have been an issue in this incident based off the rep¿s knowledge of the procedure set-up.What¿s the blue sheet in the photograph? ¿be-light¿ drape that is nylon material in the middle and cotton material on the sides.It is a light weight material that makes transferring patients easier.Additional information was requested, and the following was obtained: was the snap being held in her hand or was it clipped to her scrubs? surgeon was using snap as a bipolar forcep touching the bovie pen to it, as she usually does.Surgeon said there was redness on the side of her hand which was touching the patient where the patients skin blistered.This same hand was holding the metal snap.What are the details of the incident?: cautery current arced during surgery and burnt both patient and the doctor performing the surgery.Cautery ground was switched from cautery pad underneath the patient on the bed to a sticker attached to patient's leg.Impact of incident: burn to the patient's abdomen (2nd degree, dressing applied) and to the surgeon's finger (1st degree, no dressing required, some redness noted).
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