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| Catalog Number 0847 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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| Patient Problems
Erythema (1840); Pain (1994); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696); Blister (4537)
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| Event Date 12/15/2022 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date sent: 1/13/2023.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.Additional information was requested, and the following was obtained: could you please confirm 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)? besides the burn, did the patient 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 affected (patient or user)? answer: burns are 2nd degree, though there may be a couple 3rd degree areas - still assessing.We treated with a silver foam dressing initially and now topical antibiotic ointment and a foam dressing.No adverse consequences that i am aware of besides pain.Long term effects are unknown at this time.Patient remains inpatient.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: are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to (b)(4).When were the burns first noticed? how was the patient positioned? please describe the size, location, shape of burn.How was the room set up to include patient set up and where was the pad in relation to the patient? was there anything between patient? was the pad rinsed and let dry before it on this surgical procedure? how was pad cleaned? does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? was there any patient warming blankets used? 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 or table? what generator was being used? what power levels was generator set to? what was the end factor that was being used? was a warming device used and if so brand and location? were there liquids used in prep? was urine or other fluids detected in the field after surgery? how long was the procedure? will the pad be returning for analysis? 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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Event Description
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It was reported that during a laparoscopic cholecystectomy the patient received significant burns across the back and shoulders.
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Manufacturer Narrative
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(b)(4).Date sent: 1/24/2023.Investigation summary: 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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.
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Manufacturer Narrative
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(b)(4).Date sent: 2/27/2023.Medwatch reported number: (b)(4).
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Manufacturer Narrative
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(b)(4).Date sent: 1/26/2023.Additional information was requested, and the following was obtained: are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to (b)(4).We were able to see the photos during the meeting but we are not allowed to take them with us.Being that they are children, the hospital is not allowing these photos to be shared with ethicon.When were the burns first noticed? post op.Did the procedure start as a laparotomy or a laparoscopy? please describe the size, location, shape of burn.Each patient had multiple burns.Locations were different for each patient (back, arms and legs).How was the patient positioned? supine.How was the room set up to include patient set up and where was the pad in relation to the patient? was there anything between patient? there was a sheet between most of patient and mega soft pad, but the burns look to be where the patients skin was in direct contact with the mega soft pad.Was the pad rinsed and let dry before it on this surgical procedure? no, the hospital wasn¿t aware of/practicing this step.How was pad cleaned? i can¿t remember what they use between cases, but for terminal cleaning they use microkill q3 see image.Does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? no.Was there any patient warming blankets used? yes, i believe 3 different types.If yes what warming blankets were used? i don¿t know direct names, but a bair hugger over the lower half of the patient, and underbody fluid warming pad, and then also warming pads that went over the patients arms.To note, charting states patients body temperature never exceeded 37 degrees celsius throughout the case.What brand of warming blanket was used? see above.Is it possible the patient was in contact with a metal portion of the or table? what generator was being used? what power levels was generator set to? what was the end factor that was being used? was a warming device used and if so brand and location? see above.Were there liquids used in prep? was urine or other fluids detected in the field after surgery? how long was the procedure? long.I can¿t remember exact, but one was at least 12hrs and another 7-8hrs.Will the pad be returning for analysis? i do want to note, after meeting with hospital administration, staff involved, wound care, and environmental services, it¿s being investigated as a chemical burn as well.The patient images show the burn ending in sharp straight line, perhaps where the linen sheet covering majority of the megasoft pad was.A theory discussed, with the megasoft pad never being rinsed with water, that during the case, it¿s possible the patient had diaphoresis which could have re-activated the cleaning agent.
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Manufacturer Narrative
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(b)(4).Date sent: 3/9/2023.Additional information received: there was a patient with burns on the back.The reps did see the photos of the patient and there was a burn (reddish/brown).There was a sheet on the pad and where the patient was lying on the pad, there was the burn.The burn was around the shoulder blade.The pads are not back in circulation.The burns were noticed in the recovery room.The pad was in direct contact with the patient since the patient¿s arm was bent.There was a water warming device under the pad.The account is looking for a chemical burn relating to this issue.The account is now cleaning the pad according to the ifu and the sheet is now fully between the pad and the patient, and no part of the patient is directly touching the pad and since then there has not been any issue with the hospital.The pads were perfectly intact and not damaged at all and they had not expired.Photo analysis: this is an analysis of a set of images submitted for evaluation.Images: two photos associated with (b)(4) are assessed.Photo labelled as (b)(6) shows atypical skin injury located at left upper back with possible extension to left upper arm.The skin injury has a very sharp low edge.Some dark skin peels and superficial sludge are visible in the affected area.The presentation appears to be second degree skin injury.Photo labelled as (b)(6) shows relatively less severe skin injury of right arm pit area.The skin lesion looks dark red with possible some blisters on top but no skin breakage is seen.The injury also appears to be second degree.It should be noted that the skin injuries seen on both photos do not look like a typical electric burn injury.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.
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Manufacturer Narrative
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(b)(4), date sent: 5/17/2023.See attached notes.
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Manufacturer Narrative
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(b)(4).Date sent: 5/15/2023.Photo analysis: this is an analysis of an image submitted for evaluation.A single photograph of a patient's limb related to (b)(4) was reviewed.It is not clear when the photo was taken after the patient's surgery.However, scattered skin burn scabs were seen on the lateral area of the limb.Burn details could not be assessed due to low resolution of the photo, but no obvious skin blistering or swelling was observed.Based on the photo, the severity of the skin burns may be first to second degree.Based on the photo, the reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.H10 from photo analysis.The analysis below was not meant for this file.Images: two photos associated with (b)(4) are assessed.Photo labelled as (b)(4) shows atypical skin injury located at left upper back with possible extension to left upper arm.The skin injury has a very sharp low edge.Some dark skin peels and superficial sludge are visible in the affected area.The presentation appears to be second degree skin injury.Photo labelled as (b)(4) shows relatively less severe skin injury of right arm pit area.The skin lesion looks dark red with possible some blisters on top but no skin breakage is seen.The injury also appears to be second degree.It should be noted that the skin injuries seen on both photos do not look like a typical electric burn injury.
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Search Alerts/Recalls
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