MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-26 for SEDASYS CONTROL UNIT SEDPRU01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[24134886]
(b)(4). Information is unavailable; device was not returned for evaluation. (b)(4). Additional information was requested and the following was obtained: approximate time of event in relation to the procedure: the colonoscopy had not begun; however, the propofol infusion had been started (via sedasys protocol). The patient was in the? Disinhibited stage of sedation.? Description of event: the patient started coughing (? Similar to when you begin to fall asleep and then choke on spittle? ). ? The coughing quickly escalated to choking without moving air?. This observation was clarified and was assumed to be laryngeal spasm because the patient? S body was moving as though she was coughing, but no sound of coughing or air movement was occurring. The nurse confirmed this was the case. Anesthesiology called: anesthesiology was called immediately when they realized the patient was not? Moving air? (per their policy to call anesthesiology if a bag mask is thought to be necessary). An anesthesiologist and a crna quickly entered the room. The nurse did not recall if the patient? S vital signs were abnormal. She did not recall the o2 saturation or o2 use. Anesthesiology actions: the md and crna went to the head of the bed and performed a head tilt, chin lift, jaw thrust, and suction. There was no intubation or advanced airway manipulation techniques. The bag mask was set up but not used. The anesthesiologist performed the maneuvers. Sedasys drug delivery: the propofol infusion was stopped at the same time they called anesthesiology for help. Patient status: within a few minutes after the propofol delivery was discontinued, the patient was? Conscious? And able to maintain her own airway. Procedure status: at a later time, the propofol infusion was restarted and the colonoscopy was completed without further complication. Discharge status: the patient was discharged home the same day and there have been no known further complications. 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. What is the date of the event? What is the age of the patient? What is the patient's height and weight? What type of medications is the patient taking? What procedural premeds were given to the patient? What is the patient's past medical history/asa status? (does the patient have asthma, obstructive sleep apnea, recent cold, post nasal drip, smoker, gerd-gi reflux, diabetes, hiatal hernia, npo status, body mass index? ); which are all conditions that increase the risk of aspiration and subsequently increase the probability of laryngeal spasm. Was clinician response mode or patient response mode used? What was the propofol infusion rates with time of infusion/total volume of drug delivered before adverse event? Vital signs/any abnormalities or instability during the event: (if yes, then what are the lowest values and their corresponding durations): was there any airway management before anesthesiology team arrival? Oxygen use/delivery system with liter amount before and after anesthesiology team arrival?
Patient Sequence No: 1, Text Type: N, H10
[24134887]
It was reported that during a colonoscopy, the patient experienced a laryngospasm. There is no additional information at this time. The device will not be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2015-00021 |
| MDR Report Key | 5032379 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-11 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-08-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| 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 | 2015-08-26 |
| Model Number | NA |
| Catalog Number | SEDPRU01 |
| Lot Number | NA |
| 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 452422803 US 452422803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-26 |