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(b)(4).Date sent: 2/22/2024.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.Additional information received: in a chemo port insertion procedure on a patient in a supine position with bolster support, sharing below gist for reference : 1.Pre-operative preparation: the patient underwent routine skin preparation using hospi safe and lysowash plus (no betadine used) 2.Guidewire insertion: the surgeon inserted a ptfe-coated guidewire through the neck and into the chest for chemo port placement 3.Imaging and incision: a c-arm x-ray was taken, and the surgeon made an incision with a scalpel 4.Energy source activation: the surgeon began the procedure using a valley lab pencil on the fx8c esu.5.Fire and burns: within seconds, fumes and then a fire was observed near the patient's back.The patient sustained burns along the guidewire insertion path and on the head, hair, patient cap and skin of the neck and upper back.Both whitening and blackening of the skin were present 6.Case cancellation and observation: due to the burns, the procedure was aborted, and the patient was transferred to the icu for monitoring.A plastic surgeon confirmed the burns were deep.Is the megadyne pad currently being used in the facility.- removed after this incident is there any damage(s) noted on the pad?- no damage.How long has the account been using mega soft?- around a year.Was the reported issue at the pad site or alternate site?- both, the pad was placed on the bolster till the lower back of the patient.The bolster was placed just below the neck.Was there anything between patient and the pad (ex.Sheet, drape, etc.)?- 2 linen and underpad between the patient and megasoft, megasoft was wrapped in a blue sheet was there any patient warming blankets used? on top of the patient what generator was being used?- covidien, fx8c.What power levels was generator set to? ¿ 40-40 blend.What is the age of the patient?- 55-60 yrs.Sn of megasoft ¿ (b)(6), code number- 0800 , expiry- 2024-09.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 any arching or sparking was visible during activation while using the pencil? does the surgeon believe there is an alleged deficiency to the device that led to patient burn and fire and if so why? are there any photos of the burn (s) that you could share with us in regards to the burn? · if yes, please send to (b)(4).Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? is it standard or procedure to use hospi safe and lysowash plus products? based on internal investigation can you determine the source where they burn may have started? was there pooling of the prep solution in the area of the burn/near patients back? was the prep solution able to dry before the beginning of the surgery? can we please get a photo of the set up of the or room? what is meant by ¿underpad¿ between the patient and megasoft pad? where in the equipment was noticed of the flash flame or fire? was it at the pencil? was it at the mega soft pad or somewhere else? when were the burns first noticed? which generator was being used? fx8c or fx8-c.Was a sheath on the pad used (0825)? 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 patient? 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 patient? what was the surgical procedure? what was the surgical procedure date? how long did the surgical procedure last? what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? was the pad rinsed with water and let dry before this surgical procedure? how was the patient positioned? is it possible the patient was in contact with a metal portion of the or table? how was the room set up to include patient set up and where was the pad in relation to the patient? were there liquids used in prep? what skin preparation regiment was utilized for the procedure? was urine or other fluids detected in the field after surgery? what temperature setting was used on the warming device(s)? was there any diminished effect of the generator noted during the surgery? what monopolar disposables were used during the procedure? what ethnicity is the patient? 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.The device history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.
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(b)(4).Date sent: 3/1/2024.Additional information received: burn was all across guidewire and on upper back in shape of amoeba (7-8 cm),skin whitening at neck and skin peeled off.Fire occured from back side ehere skin whitening was seen.There was no damage to the pad from the fire and also before that.Patient is on path recovering from wound ¿ plastic surgery undertaken.¿ awaiting chemotherapy ¿ recovering from shock ¿ patient planning to pursue legal action.Additional details from procedure: the patient was under general anesthesia & intubation.Under pad ( an absorbent type sheet) along with couple of linen drape was placed/used in this procedure (hospital could not verify if this was usual practice in all procedures with megasoft pad).The esu was set 40-45 and was not applied more than 5 secs.Flame emerged behind the right shoulder, further burning hair strands of patients.Copious quantity of saline was used to douse the fire.Patient showed no signs incidental arrythmia.No burns were observed at the site of guidewire on additional details related to the incident: patient consent for sharing photograph unlikely.Plastic surgeon who attended and managed the case will share detailed brief along with diagrammatic representation if possible.
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(b)(4).Date sent: 3/12/2024.Investigation summary the pad and cable were functionally tested by connecting the pad to the generator and no alerts were displayed.There were no anomalies found during the functional test that include continuity testing.Although no product defect was identified during functional testing, 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.A review of this reported event was conducted by a cross functional team to include engineering and medical personnel.During the review of the reported event, it was noted that liquid hospisafe cleaning solution was used on the patient prior to the surgical procedure.This cleaning solution was noted to be a 70% alcohol solution.The megadyne¿ mega 2000¿ reusable patient return electrode instructions for use has the following warning regarding solutions such as hospisafe being used in electrosurgical procedures that may have contributed to this event.
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(b)(4).Date sent: 3/5/2024.Additional information was requested, and the following was obtained: 1.Was any arching of sparking being visible during activation while using the pencil? ans- no visible arching or sparking noted.2.Does surgeon believe there is an alleged deficiency to the device that led to patient burn & fire and it so why? ans- company to answer 3.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and it so why? ans-j n j to answer 4.Based on internal investigation can you determine the source where the burn may have started? ans- no 5.Was there pooling of the prer solution in the area of the burn/near patients back? ans- no 6.Was the prep solution able to dry before the beginning of the surgery? ans- yes it was absolutely dry.7.Can we please get a photo of the set up of the or room? ans-no 8.What is meant by ¿underpad¿ between the patient and megasoft pad? ans- absorbable pad.9.Where in the equipment was noticed of the flash flame or fire? was it at the pencil? ans- no flash / flame noticed at pencil.10.Was it at the mega saft pad or somewhere else? ans- burn was there 11.Which generator was being used? f*8c or f*8-c ans- fx-8c 12.What is the severity of the burn? (please see degrees of burns below & choose one) description (image attached as well): 1) burn wounds involving the anterior chest wall, breast, lateral neck and upper lateral back on the right side.2) area involved is about 5 % total body surface area 3) the burn wounds are of mixed depth and are of superficial and deep second degree type.4) areas in the anterior chest wall , breast and medial upper back are mostly deep second degree burn 5) areas in the medial aspect of the breast and upper back outer aspect are of superficial second degree type.13.What medical intervention was used to treat the burn ( such as salve or stitches)? ans-given¿ dressing done by plastic surgeon.Pod 3 underwent debridement and split skin grafting.14.Bedsides the burn,did the patient experience any adverse consequence due to the issue? ans- no.15.Are there any anticipated long ¿term effects from the burn or injury? ans : psychological, scarring local visible parts.Cosmetic issues.16.What is the current status of the patient? ans-stable.Post skin grafting vac dressings on psychologically disturbed.17.How was the patient positioned ? ans-supine position 18.Is it possible the patient was in contact with a metal portion of the or table? ans-no 19.What temperature setting was used on the warming device (s)? ans- warmer wasn¿t in use 20.Was there any diminished effect of the generator noted during the surgery? no.What was the surgical procedure? chemoport insertion.What was the surgical procedure date? (b)(6).How long did the surgical procedure last? procedure abandoned.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? cleaned with saline and dried.Was the pad rinsed with water and let dry before this surgical procedure? yes.How was the room set up to include patient set up and where was the pad in relation to the patient? pad then 2 linens and then the patient.Were there liquids used in prep? yes.What skin preparation regiment was utilized for the procedure? hospi safe and lyso wash.Was urine or other fluids detected in the field after surgery? no.What monopolar disposables were used during the procedure? valley lab.What ethnicity is the patient? indian.Additional information received: the patient is not giving consent to share the actual picture of the injury so the same cannot be made available for investigation.
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(b)(4).Date sent: 3/6/2024.Investigation summary.The product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that the 0800 pad and pigtail cable were returned with no apparent damage.The pad was connected to the generator and no anomalies were noted.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 gs23001019, and no non-conformances were identified.
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