MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for COUPLER, HD, 19.5MM 72201635 manufactured by Smith & Nephew, Inc..
[80997713]
Patient Sequence No: 1, Text Type: N, H10
[80997714]
There has been a defect in the camera console side attachment of camera head. During surgery, the surgeon is not able to get perfect resolution picture. The picture gets blurred occasionally. Due to this issue, the surgeon had to use a non-smith and nephew system which has been working for years. The surgeon is not happy with the smith and nephew system. No injuries or complications were reported as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2017-00075 |
| MDR Report Key | 6735455 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-07-24 |
| 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 | MR. JIM GONZALES |
| Manufacturer Street | 7000 W 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 | COUPLER, HD, 19.5MM |
| Generic Name | INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE |
| Product Code | FEI |
| Date Received | 2017-07-24 |
| Catalog Number | 72201635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-24 |