MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for PUMP A127 GOFLO 72204968 manufactured by Smith & Nephew, Inc..
[109689029]
Patient Sequence No: 1, Text Type: N, H10
[109689030]
It was reported that during surgery, the water pressure of the pump rise rapidly and the pump turned quickly, so the water was lowered to 5, but the pump constantly turned quickly and interrupted the op. Obstruction of vision. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[117889484]
An evaluation was performed by the supplier and could not confirm the customer complaint for the water pressure of the pump raised rapidly and the pump turned quickly. A visual inspection was performed and showed the pump in good general condition. Functional inspection showed the return device passed all criteria. This included a flow test, pressure test, and an rpm test with a result of pass. All functional testing did not identify any functional abnormalities. No errors were triggered during any of the testing. No manufacturing related defects were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2018-00086 |
| MDR Report Key | 7553443 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-05-30 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PUMP A127 GOFLO |
| Generic Name | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
| Product Code | FEQ |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-06-29 |
| Model Number | A127 |
| Catalog Number | 72204968 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-30 |