MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SMOKE EVACUATOR; MEGADYNE¿ SMOKE EVACUATOR

Model Number MESE1

Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993); Ventilation Problem in Device Environment (3027)

Patient Problems Burn(s) (1757); Unspecified Tissue Injury (4559)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the serial number was not provided.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: is the mese1 currently being used in the facility? if no, why not? 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).Are there any anticipated long-term effects from the burn or bowel resection surgery? what is the current status of the patient? does the surgeon believe there is there an alleged deficiency to the mese1 that led to patient burn and if so why? did the co2 insufflator stop working? was there continuous activation for the mese1? please confirm the surgical procedure? what type of co2 insufflator was being used? what was the setting of the co2insufflator? was the co2 insufflator set to auto or was it set manually? what are the default pressure settings for this procedure (for the co2 insufflator and for the mese1)? what energy devices were used in the procedure that could have contributed or may have caused the bowel injury? were there any issues with the trocars that could lead to the loss of the abdominal pressure? any unusual noises from smoke evacuator? why do you believe the smoke evacuator caused or contributed to the issue? what were the smoke evacuators settings for this procedure? was the mese1 in open or lap mode? what was the flow rate and run time settings? how was the system set up? was the mese1 connected to the room or the hospital exhaust system? was the connect cable used? was the handheld device being used with the rf sensor? what was the handheld device that led to the bowel injury? how was the surgeon activating the hand held device? how many trocars were in use? were the stop cock closed with all of the trocars and the only trocars opened were the one connected to the insufflator and mese1? what sizes of trocars were being used? what is the serial number of the mese1? can this mese1 be returned for a device analysis? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a vaginal hysterectomy and at time of colpotomy there was a sudden drop in intraabdominal pressure where they think the smoke evac system was excessive.Patient had a thermal bowel injury at this time and has since gone onto have a bowel resection and experience significant harm.Was procedure successfully completed? yes.If yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? thermal bowel injury.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes.If yes, describe: bowel resection.

Manufacturer Narrative

(b)(4), date sent: 2/22/2022.Additional information was requested, and the following was obtained: is the mese1 currently being used in the facility? it has been removed from use and will be sent back to jjm for testing are there any photos of the burn that you could share with us in regards to the burn? no are there any anticipated long-term effects from the burn or bowel resection surgery? what is the current status of the patient? patient had a bowel resection due to the thermal injury.Current status unknown.It is still unclear which device (thunderbeat or diathermy l-hook) did this and when in the procedure.Does the surgeon believe there is there an alleged deficiency to the mese1 that led to patient burn and if so why? the surgeon believes the mese1 was not working during his use of the thunderbeat.We have uncovered the thunderbeat machine was not connected to the mese1 at the time l.C (cnc) and b.S.(cn) of hospital and i believe there may have been a number of factors leading to the situation that happened.We do not believe at this point that the mese1 was operating incorrectly.It was set up incorrectly and used incorrectly along with a number of human factors, possibly including the patient being unrelaxed during the incident causing the abdomen to tighten and collapse, of which we will never know and is hypothetical.Did the co2 insufflator stop working? no was there continuous activation for the mese1? no please confirm the surgical procedure? lap hysterectomy what type of co2 insufflator was being used? stryker what was the setting of the co2insufflator? 14-16 was the co2 insufflator set to auto or was it set manually? manually what are the default pressure settings for this procedure (for the co2 insufflator and for the mese1)? unknown what energy devices were used in the procedure that could have contributed or may have caused the bowel injury? a lap l-hook and thunderbeat.Were there any issues with the trocars that could lead to the loss of the abdominal pressure? unknown any unusual noises from smoke evacuator? no why do you believe the smoke evacuator caused or contributed to the issue? it was initially raised because of the lack of smoke evacuation and then the sudden loss of intra-abdominal pressure what were the smoke evacuators settings for this procedure? level 2 on both run time and flow rate was the mese1 in open or lap mode? lap what was the flow rate and run time settings? level 2 how was the system set up? it was on a megadyne cart with a connect cable plugged into a medtronic ft-10 generator sitting above it.Was the mese1 connected to the room or the hospital exhaust system? no was the connect cable used? yes, plugged into the medtronic ft-10 generator was the handheld device being used with the rf sensor? unknown what was the handheld device that led to the bowel injury? the surgeon believes it was the heat from the tissue on the vaginal vault which was incised with the lap l-hook.How was the surgeon activating the hand held device? l-hook by foot, thunderbeat by hand how many trocars were in use? unknown were the stop cock closed with all of the trocars and the only trocars opened were the one connected to the insufflator and mese1? unknown what sizes of trocars were being used? various 5mm and 12mm what is the serial number of the mese1? (b)(6) can this mese1 be returned for a device analysis? yes serial number : (b)(6).

Manufacturer Narrative

(b)(4).Date sent; 3/8/2022.

Manufacturer Narrative

(b)(4).Date sent: 3/24/2022.Investigation summary per service manual operational and diagnostic analysis confirmed the reported issue.The solenoid valve was replaced as identified in the investigation to address the issue and the unit was re-calibrated.Additionally, the power switch was replaced.This was unrelated to the reported issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

Manufacturer Narrative

(b)(4).Date sent: 4/20/2022.Additional information was requested, and the following was obtained: what does it mean when it is stated that ¿we have uncovered the thunderbeat machine was not connected to the mese1 at the time l.C (cnc) and b.S.(cn) of hospital and i believe there may have been a number of factors leading to the situation that happened.¿? later in the same note it states that the mese1 was connected to a ft10 via the connect cable.We are just trying to understand what is meant by the mese1 not being connected.The megadyne smoke evac was connected to the medtronic ft-10 diathermy machine and would activate properly when diathermy was used.They had an olympus advanced energy and diathermy generator next to the megadyne se up but the connect cable was plugged into the back of the ft-10 not the olympus generator meaning when the surgeon used the thunderbeat with the olympus generator the smoke evac would not work (hence no connect cable? ¿ what is meant by set up incorrectly and used incorrectly? if they wanted the smoke evac to work while using the olympus thunderbeat device the connect cable would have to be connected to the olympus generator not the medtronic ft-10 does the health care professional/surgeon believe there is alleged deficiency to the mese1 that caused the burn/injury? if yes, why? they want to know if the smoke evac has the ability to inadvertently quickly suck/remove all the gas out of the abdomen causing the loss of abdominal pressure and pneumoperitoneum.Which device was being activated when insufflation was lost? the devices used where the olympus thunderbeat which was not connected to the smoke evacuator and the lap l-hook which was connected to smoke evac.

Manufacturer Narrative

(b)(4).Date sent: 3/1/2023.Additional information : the biomedical engineer is also suspecting that unit was too sensitive so when the autoactivation function came on when it is not supposed to, and deflated the pneumoperitoneum leading to patient burn.H6 investigation findings c19.

• Brand Name: SMOKE EVACUATOR
• Type of Device: MEGADYNE¿ SMOKE EVACUATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 13357812
• MDR Text Key: 289192744
• Report Number: 1721194-2022-00004
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559104545
• UDI-Public: 10614559104545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MESE1
• Device Catalogue Number: MESE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention