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| Model Number MA1200-PM |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Partial thickness (Second Degree) Burn (2694)
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| Event Date 11/15/2021 |
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Event Type
malfunction
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Event Description
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Injury description: young patient experienced a burn injury on the left dorsal forearm and right 5th digit.4cm in length, but interrupted, only partially through the dermis.This was dressed with bacitracin ointment and telfa.Burn is partial thickness; unknown cause (possible chemical, thermal, friction); minor treatment with bacitracin and dressing for 2 weeks; no functional deficit anticipated, though some slight discoloration may be seen.The injury was discovered while removing draping from the patient after the procedure.The or team noted that the area of the burn had been in contact with the reflective side of the mistral-air warming blanket for the duration of the procedure (approx.40 minutes - 1 hour).Initially, it was thought that the burn was caused by heat from the warming unit, as it had been set to the maximum heat setting of 43 degc.Subsequent investigation and testing by the supplier found that the mistral-air warming unit was heating air to temperatures within acceptable parameters.However, additional testing of the mistral-air warming blanket showed that the reflective material present on one side can conduct electricity at the power levels (10-30w) used during electrosurgery.The focus of the investigation then shifted to the concern that the application of the reflective material to the patient's skin may have created an alternate site to ground during the procedure, resulting in the burn.Manufacturer response for electrosurgical, cutting coagulation accessories, mega soft (per site reporter).Mfr alerted to the event earlier this year by our facility's clinical engineering, who spoke with a company technical services representative over the phone.The representative was highly knowledgeable about the design and theory of operation of the megasoft return electrodes.The representative had no previous experience with any potential interactions between the mistral air warming blanket and the megasoft return electrode.However, he was highly concerned about the facility's or setup, specifically with the stack up of layers between the patient and the return electrode.He was especially concerned about the increase in distance between patient and electrode that occurs when the mistral air blanket is inflated.He stated that the amount of material being placed between the patient and the electrode could absolutely impact the ability of the electrode to safely complete a circuit with the esu.The representative stated that, given enough impedance between the patient and the megasoft return electrode, electrical energy in the patient introduced at the surgical site would seek alternate routes to ground.Should the patient come into contact with a conductive surface connected to ground, current will exit the patient at the site of contact.Earlier this month, a meeting between our facility and several megadyne engineering and quality representatives was held.The megadyne representatives concurred with the previous representative's assessment, though they were less concerned about the separation of distance between the patient and the return electrode when an air-warming device was in use.According to their assessment, a warming blanket between the patient and the pad should not be an issue as long as the blanket remains deflated under the patient's weight.Their only concern would be if is the patient is "floating" during a procedure - i.E., completely being supported off the pad by the inflated warming blanket.The megasoft ifu does not address how to position the device when a forced-air warming device is being used.Currently, the only guidance in the megasoft pad ifu with respect to material being placed between the patient and the pad is "do not place excessive amounts of linens or other materials between the patient and the mega soft.Return electrode.The use of excessive material between the patient and electrode assembly may result in a diminished electrosurgical effect.A sheet and draw sheet may be placed over the mega soft [electrode]." megadyne/ethicon published a white paper in 2020 on the theory of operation of the megasoft return electrode.On page 6, this paper states, "the mega soft¿ return electrode can be used with warming pads.The electrode needs to be placed on top of the warming pad to minimize separation between the patient and the electrode." during the meeting, the megadyne representatives were reluctant to recommend one method over the other.A request was made by our team that the ifu be updated to include information on how to position the return electrode while a warming pad is being used, but the representatives demurred.They did not believe that an update to the ifu was necessary given that the only risk associated with decreased capacitive coupling is diminished electrosurgical effect at the surgical site.However, they are still in the process of conducting their investigation.Manufacturer response for system, thermal regulating, mistral-air (per site reporter).The mistral-air system is sold in the united states by stryker.The manufacturer the surgical company b.V.Was made aware of this issue by stryker.Stryker was made aware of this event shortly after it occurred.A stryker representative visited our facility and performed air temperature testing on this mistral-air ma1200-pm unit per stryker procedure.The unit's temperature output was found to be within tolerance.Our clinical engineering had also tested the temperature output of the unit shortly after the event date and found the unit to be functioning within tolerance.In response to our concerns that in-house testing showed the reflective material on mistral-air blankets is conductive, stryker has reached out to the surgical company b.V.Regarding the results of conductivity testing that was performed to support recall z-0419-2018.We have yet to receive this test data from either stryker or the surgical company b.V., nor have we been contacted directly by the surgical company b.V.
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Event Description
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Injury description: young patient experienced a burn injury on the left dorsal forearm and right 5th digit.4cm in length, but interrupted, only partially through the dermis.This was dressed with bacitracin ointment and telfa.Burn is partial thickness; unknown cause (possible chemical, thermal, friction); minor treatment with bacitracin and dressing for 2 weeks; no functional deficit anticipated, though some slight discoloration may be seen.The injury was discovered while removing draping from the patient after the procedure.The or team noted that the area of the burn had been in contact with the reflective side of the mistral-air warming blanket for the duration of the procedure (approx.40 minutes - 1 hour).Initially, it was thought that the burn was caused by heat from the warming unit, as it had been set to the maximum heat setting of 43 degc.Subsequent investigation and testing by the supplier found that the mistral-air warming unit was heating air to temperatures within acceptable parameters.However, additional testing of the mistral-air warming blanket showed that the reflective material present on one side can conduct electricity at the power levels (10-30w) used during electrosurgery.The focus of the investigation then shifted to the concern that the application of the reflective material to the patient's skin may have created an alternate site to ground during the procedure, resulting in the burn.
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manufacturer response for electrosurgical, cutting coagulation accessories, mega soft (per site reporter)
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mfr alerted to the event earlier this year by our facility's clinical engineering, who spoke with a company technical services representative over the phone.The representative was highly knowledgeable about the design and theory of operation of the megasoft return electrodes.The representative had no previous experience with any potential interactions between the mistral air warming blanket and the megasoft return electrode.However, he was highly concerned about the facility's or setup, specifically with the stack up of layers between the patient and the return electrode.He was especially concerned about the increase in distance between patient and electrode that occurs when the mistral air blanket is inflated.He stated that the amount of material being placed between the patient and the electrode could absolutely impact the ability of the electrode to safely complete a circuit with the esu.The representative stated that, given enough impedance between the patient and the megasoft return electrode, electrical energy in the patient introduced at the surgical site would seek alternate routes to ground.Should the patient come into contact with a conductive surface connected to ground, current will exit the patient at the site of contact.Earlier this month, a meeting between our facility and several megadyne engineering and quality representatives was held.The megadyne representatives concurred with the previous representative's assessment, though they were less concerned about the separation of distance between the patient and the return electrode when an air-warming device was in use.According to their assessment, a warming blanket between the patient and the pad should not be an issue as long as the blanket remains deflated under the patient's weight.Their only concern would be if is the patient is "floating" during a procedure - i.E., completely being supported off the pad by the inflated warming blanket.The megasoft ifu does not address how to position the device when a forced-air warming device is being used.Currently, the only guidance in the megasoft pad ifu with respect to material being placed between the patient and the pad is "do not place excessive amounts of linens or other materials between the patient and the mega soft.Return electrode.The use of excessive material between the patient and electrode assembly may result in a diminished electrosurgical effect.A sheet and draw sheet may be placed over the mega soft [electrode]." megadyne/ethicon published a white paper in 2020 on the theory of operation of the megasoft return electrode.On page 6, this paper states, "the mega soft¿ return electrode can be used with warming pads.The electrode needs to be placed on top of the warming pad to minimize separation between the patient and the electrode." during the meeting, the megadyne representatives were reluctant to recommend one method over the other.A request was made by our team that the ifu be updated to include information on how to position the return electrode while a warming pad is being used, but the representatives demurred.They did not believe that an update to the ifu was necessary given that the only risk associated with decreased capacitive coupling is diminished electrosurgical effect at the surgical site.However, they are still in the process of conducting their investigation.
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manufacturer response for system, thermal regulating, mistral-air (per site reporter)
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the mistral-air system is sold in the united states by stryker.The manufacturer the surgical company b.V.Was made aware of this issue by stryker.Stryker was made aware of this event shortly after it occurred.A stryker representative visited our facility and performed air temperature testing on this mistral-air ma1200-pm unit per stryker procedure.The unit's temperature output was found to be within tolerance.Our clinical engineering had also tested the temperature output of the unit shortly after the event date and found the unit to be functioning within tolerance.In response to our concerns that in-house testing showed the reflective material on mistral-air blankets is conductive, stryker has reached out to the surgical company b.V.Regarding the results of conductivity testing that was performed to support recall z-0419-2018.We have yet to receive this test data from either stryker or the surgical company b.V., nor have we been contacted directly by the surgical company b.V.
|
| |
|
Event Description
|
|
Injury description: young patient experienced a burn injury on the left dorsal forearm and right 5th digit.4cm in length, but interrupted, only partially through the dermis.This was dressed with bacitracin ointment and telfa.Burn is partial thickness; unknown cause (possible chemical, thermal, friction); minor treatment with bacitracin and dressing for 2 weeks; no functional deficit anticipated, though some slight discoloration may be seen.The injury was discovered while removing draping from the patient after the procedure.The or team noted that the area of the burn had been in contact with the reflective side of the mistral-air warming blanket for the duration of the procedure (approx.40 minutes - 1 hour).Initially, it was thought that the burn was caused by heat from the warming unit, as it had been set to the maximum heat setting of 43 degc.Subsequent investigation and testing by the supplier found that the mistral-air warming unit was heating air to temperatures within acceptable parameters.However, additional testing of the mistral-air warming blanket showed that the reflective material present on one side can conduct electricity at the power levels (10-30w) used during electrosurgery.The focus of the investigation then shifted to the concern that the application of the reflective material to the patient's skin may have created an alternate site to ground during the procedure, resulting in the burn.Manufacturer response for electrosurgical, cutting coagulation accessories, mega soft (per site reporter).Mfr alerted to the event earlier this year by our facility's clinical engineering, who spoke with a company technical services representative over the phone.The representative was highly knowledgeable about the design and theory of operation of the megasoft return electrodes.The representative had no previous experience with any potential interactions between the mistral air warming blanket and the megasoft return electrode.However, he was highly concerned about the facility's or setup, specifically with the stack up of layers between the patient and the return electrode.He was especially concerned about the increase in distance between patient and electrode that occurs when the mistral air blanket is inflated.He stated that the amount of material being placed between the patient and the electrode could absolutely impact the ability of the electrode to safely complete a circuit with the esu.The representative stated that, given enough impedance between the patient and the megasoft return electrode, electrical energy in the patient introduced at the surgical site would seek alternate routes to ground.Should the patient come into contact with a conductive surface connected to ground, current will exit the patient at the site of contact.Earlier this month, a meeting between our facility and several megadyne engineering and quality representatives was held.The megadyne representatives concurred with the previous representative's assessment, though they were less concerned about the separation of distance between the patient and the return electrode when an air-warming device was in use.According to their assessment, a warming blanket between the patient and the pad should not be an issue as long as the blanket remains deflated under the patient's weight.Their only concern would be if is the patient is "floating" during a procedure - i.E., completely being supported off the pad by the inflated warming blanket.The megasoft ifu does not address how to position the device when a forced-air warming device is being used.Currently, the only guidance in the megasoft pad ifu with respect to material being placed between the patient and the pad is "do not place excessive amounts of linens or other materials between the patient and the mega soft.Return electrode.The use of excessive material between the patient and electrode assembly may result in a diminished electrosurgical effect.A sheet and draw sheet may be placed over the mega soft [electrode]." megadyne/ethicon published a white paper in 2020 on the theory of operation of the megasoft return electrode.On page 6, this paper states, "the mega soft¿ return electrode can be used with warming pads.The electrode needs to be placed on top of the warming pad to minimize separation between the patient and the electrode." during the meeting, the megadyne representatives were reluctant to recommend one method over the other.A request was made by our team that the ifu be updated to include information on how to position the return electrode while a warming pad is being used, but the representatives demurred.They did not believe that an update to the ifu was necessary given that the only risk associated with decreased capacitive coupling is diminished electrosurgical effect at the surgical site.However, they are still in the process of conducting their investigation.Manufacturer response for system, thermal regulating, mistral-air (per site reporter).The mistral-air system is sold in the united states by stryker.The manufacturer the surgical company b.V.Was made aware of this issue by stryker.Stryker was made aware of this event shortly after it occurred.A stryker representative visited our facility and performed air temperature testing on this mistral-air ma1200-pm unit per stryker procedure.The unit's temperature output was found to be within tolerance.Our clinical engineering had also tested the temperature output of the unit shortly after the event date and found the unit to be functioning within tolerance.In response to our concerns that in-house testing showed the reflective material on mistral-air blankets is conductive, stryker has reached out to the surgical company b.V.Regarding the results of conductivity testing that was performed to support recall z-0419-2018.We have yet to receive this test data from either stryker or the surgical company b.V., nor have we been contacted directly by the surgical company b.V.
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|
Event Description
|
|
Injury description: young patient experienced a burn injury on the left dorsal forearm and right 5th digit.4cm in length, but interrupted, only partially through the dermis.This was dressed with bacitracin ointment and telfa.Burn is partial thickness; unknown cause (possible chemical, thermal, friction); minor treatment with bacitracin and dressing for 2 weeks; no functional deficit anticipated, though some slight discoloration may be seen.The injury was discovered while removing draping from the patient after the procedure.The or team noted that the area of the burn had been in contact with the reflective side of the mistral-air warming blanket for the duration of the procedure (approx.40 minutes - 1 hour).Initially, it was thought that the burn was caused by heat from the warming unit, as it had been set to the maximum heat setting of 43 degc.Subsequent investigation and testing by the supplier found that the mistral-air warming unit was heating air to temperatures within acceptable parameters.However, additional testing of the mistral-air warming blanket showed that the reflective material present on one side can conduct electricity at the power levels (10-30w) used during electrosurgery.The focus of the investigation then shifted to the concern that the application of the reflective material to the patient's skin may have created an alternate site to ground during the procedure, resulting in the burn.Manufacturer response for electrosurgical, cutting coagulation accessories, mega soft (per site reporter).Mfr alerted to the event earlier this year by our facility's clinical engineering, who spoke with a company technical services representative over the phone.The representative was highly knowledgeable about the design and theory of operation of the megasoft return electrodes.The representative had no previous experience with any potential interactions between the mistral air warming blanket and the megasoft return electrode.However, he was highly concerned about the facility's or setup, specifically with the stack up of layers between the patient and the return electrode.He was especially concerned about the increase in distance between patient and electrode that occurs when the mistral air blanket is inflated.He stated that the amount of material being placed between the patient and the electrode could absolutely impact the ability of the electrode to safely complete a circuit with the esu.The representative stated that, given enough impedance between the patient and the megasoft return electrode, electrical energy in the patient introduced at the surgical site would seek alternate routes to ground.Should the patient come into contact with a conductive surface connected to ground, current will exit the patient at the site of contact.Earlier this month, a meeting between our facility and several megadyne engineering and quality representatives was held.The megadyne representatives concurred with the previous representative's assessment, though they were less concerned about the separation of distance between the patient and the return electrode when an air-warming device was in use.According to their assessment, a warming blanket between the patient and the pad should not be an issue as long as the blanket remains deflated under the patient's weight.Their only concern would be if is the patient is "floating" during a procedure - i.E., completely being supported off the pad by the inflated warming blanket.The megasoft ifu does not address how to position the device when a forced-air warming device is being used.Currently, the only guidance in the megasoft pad ifu with respect to material being placed between the patient and the pad is "do not place excessive amounts of linens or other materials between the patient and the mega soft.Return electrode.The use of excessive material between the patient and electrode assembly may result in a diminished electrosurgical effect.A sheet and draw sheet may be placed over the mega soft [electrode]." megadyne/ethicon published a white paper in 2020 on the theory of operation of the megasoft return electrode.On page 6, this paper states, "the mega soft¿ return electrode can be used with warming pads.The electrode needs to be placed on top of the warming pad to minimize separation between the patient and the electrode." during the meeting, the megadyne representatives were reluctant to recommend one method over the other.A request was made by our team that the ifu be updated to include information on how to position the return electrode while a warming pad is being used, but the representatives demurred.They did not believe that an update to the ifu was necessary given that the only risk associated with decreased capacitive coupling is diminished electrosurgical effect at the surgical site.However, they are still in the process of conducting their investigation.Manufacturer response for system, thermal regulating, mistral-air (per site reporter).The mistral-air system is sold in the united states by stryker.The manufacturer the surgical company b.V.Was made aware of this issue by stryker.Stryker was made aware of this event shortly after it occurred.A stryker representative visited our facility and performed air temperature testing on this mistral-air ma1200-pm unit per stryker procedure.The unit's temperature output was found to be within tolerance.Our clinical engineering had also tested the temperature output of the unit shortly after the event date and found the unit to be functioning within tolerance.In response to our concerns that in-house testing showed the reflective material on mistral-air blankets is conductive, stryker has reached out to the surgical company b.V.Regarding the results of conductivity testing that was performed to support recall z-0419-2018.We have yet to receive this test data from either stryker or the surgical company b.V., nor have we been contacted directly by the surgical company b.V.
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