MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-15 for DISPOSABLE DEFENDO A/W VALVES 100310 manufactured by Medivators.
[136261338]
The facility reported during an egd endoscopy procedure the patient's airway was obstructed. The disposable defendo air/water valve was being used during this procedure and thus contributed to the event. During an egd procedure the patient was under anesthesia and the physician reported the defendo air/water valve was sticking/leaking causing water to drip down the patient's throat. This physician reported muscle spasms of the vocal cords which blocked their airway and lead to the patient being intubated. Medivators consulted with four resident experts in gi and they all stated that it is unlikely during a procedure for the physician to leave the distal tip at the juncture of the larynx/trachea and esophagus for an extended period of time that would allow water to get into the patients' vocal cords. The purpose of the defendo air/water valve is for the physician to clear the lens to have better visibility during the procedure which limited amounts of water is used. The physician has complete control of the fluid flow through the endoscope. Regulatory has attempted to contact the facility. Any details of pre-exiting conditions about the patient were not disclosed. The current patient condition is unknown. This complaint will continue to be monitored in the medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[136261339]
The facility reported during an egd endoscopy procedure the patient's airway was obstructed. The disposable defendo air/water valve was being used during this procedure and thus contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651395-2019-00001 |
| MDR Report Key | 8343345 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-10-20 |
| Date Added to Maude | 2019-02-15 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOCK DRIVE |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE DEFENDO A/W VALVES |
| Generic Name | DISPOSABLE AIR/WATER VALVE FOR GI ENDOSCOPES |
| Product Code | ODC |
| Date Received | 2019-02-15 |
| Returned To Mfg | 2019-01-28 |
| Model Number | 100310 |
| Lot Number | 935350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOCK DRIVE CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-15 |