MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-14 for HYDRA IRRIGATION SYSTEM SIT-355 SIT-355-10 manufactured by Endochoice Inc..
[24616534]
The hydra irrigation tubing set was in use with a medivators 24-hour connector, which does not include a check valve. Therefore the only back flow valve was on the hydra irrigation tubing set. It was determined upon testing of the returned device that the valve did not function properly. Subsequent testing of this lot found no other units exhibiting this issue. Endochoice has recommended to the site that they utilize single-use connectors that include back flow valves.
Patient Sequence No: 1, Text Type: N, H10
[24616535]
A user reported that liquid gastric contents back-flowed into the irrigation tubing during a gastroscopy. There was no patient impact. An olympus 190 gastroscope was in use with mediators endogator 24-hour use irrigation port connector and the endochoice hydra irrigation tubing set. Submission of this report does not, in itself, represent a conclusion that medical device caused or contributed to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007591333-2015-00035 |
| MDR Report Key | 5008543 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-07-22 |
| Date Mfgr Received | 2015-07-28 |
| Date Added to Maude | 2015-08-17 |
| 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 Street | 11810 WILLS RD |
| Manufacturer City | ALPHARETTA GA 30009 |
| Manufacturer Country | US |
| Manufacturer Postal | 30009 |
| Manufacturer Phone | 6787084743 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDRA IRRIGATION SYSTEM |
| Generic Name | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
| Product Code | FEQ |
| Date Received | 2015-08-14 |
| Returned To Mfg | 2015-07-27 |
| Model Number | SIT-355 |
| Catalog Number | SIT-355-10 |
| Lot Number | 140520 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOCHOICE INC. |
| Manufacturer Address | 11810 WILLS RD ALPHARETTA GA 300090000 US 300090000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |