SEDASYS CONTROL UNIT SEDPRU01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-06-23 for SEDASYS CONTROL UNIT SEDPRU01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).

Event Text Entries

[5812344] It was reported via a presentation at a regional gastroenterologist meeting that the patient was undergoing an egd procedure with sedation administered with the sedasys system. The event required bag mask ventilation due to laryngospasm associated with undersedation. Additional information from the site indicated that they used the term laryngospasm to describe a patient that was agitated/coughing while the endoscopist was inserting the endoscope which elicited the? Gag reflex.? This led to transient oxygen desaturation that was resolved with bag mask ventilation. The event was caused by the stimulation of the vocal cords by the endoscope during the egd. This can occur with other modes of sedation. The event did not require calling for a code team or involving an anesthesiologist to manage the airway. Positive pressure was not required to? Break? The laryngospasm and no further airway maneuvers were required. There was no patient injury resulting from the event and the patient was routinely discharged from the facility the day of the procedure.
Patient Sequence No: 1, Text Type: D, B5


[13477925] (b)(4). Conclusion: unit not returned for evaluation. Additional information: the clinicians at the site indicated the event was not caused by the sedasys system rather the procedure itself. The site reviewed the event with their anesthesia department, which recommended they start using a topical anesthetic to numb the vocal cords prior to inserting the endoscope. Since implementing that practice in (b)(6), the site has observed no laryngospasms. After reviewing the available information we have concurred with the site, that the laryngospasm was caused by the procedure; specifically stimulation of the vocal cords by the endoscope. We have elected to report the event due to the bag mask ventilation to be consistent with our post-approval commitment to fda. Specifically, the incidence of bag-mask ventilation is a secondary endpoint of one of two required post-approval studies. The event reported did not occur in that clinical study, as that study is not slated to start until late 2016.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1527736-2015-00015
MDR Report Key4863159
Report Source05,06,07
Date Received2015-06-23
Date of Report2015-06-04
Date Mfgr Received2015-05-29
Date Added to Maude2015-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMILTON GARRETT
Manufacturer Phone5133378865
Manufacturer G1MACK MOLDING COMPANY
Manufacturer Street608 WARM BROOK RD
Manufacturer CityARLINGTON VT 05250
Manufacturer CountryUS
Manufacturer Postal Code05250
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSEDASYS CONTROL UNIT
Generic NameCOMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Product CodePDR
Date Received2015-06-23
Model NumberNA
Catalog NumberSEDPRU01
ID Number10705036010203
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO SURGERY, INC (CINCINNATI)
Manufacturer Address4545 CREEK RD CINCINNATI OH 45242280 US 45242 2803


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-06-23

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