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).
[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
| Report Number | 1527736-2015-00015 |
| MDR Report Key | 4863159 |
| Report Source | 05,06,07 |
| Date Received | 2015-06-23 |
| Date of Report | 2015-06-04 |
| Date Mfgr Received | 2015-05-29 |
| Date Added to Maude | 2015-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | MACK MOLDING COMPANY |
| Manufacturer Street | 608 WARM BROOK RD |
| Manufacturer City | ARLINGTON VT 05250 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDASYS CONTROL UNIT |
| Generic Name | COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
| Product Code | PDR |
| Date Received | 2015-06-23 |
| Model Number | NA |
| Catalog Number | SEDPRU01 |
| ID Number | 10705036010203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242280 US 45242 2803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-23 |