MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for SERV REPL, HD COUPLER, 19.5MM 72201635S manufactured by Smith & Nephew, Inc..
[79141852]
Awaiting reciept of device.
Patient Sequence No: 1, Text Type: N, H10
[79141853]
It was reported not holding. No delay was noted. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[115968452]
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product to look at. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated. Our quality department will continue to monitor for trends. No further investigation is required. A review of the device history record was performed which confirmed no inconsistencies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2017-00069 |
| MDR Report Key | 6687554 |
| Date Received | 2017-07-05 |
| Date of Report | 2018-03-08 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-07-05 |
| 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 W. WILLIAM CANNON |
| 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 | SERV REPL, HD COUPLER, 19.5MM |
| Generic Name | INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE |
| Product Code | FEI |
| Date Received | 2017-07-05 |
| Returned To Mfg | 2018-02-26 |
| Catalog Number | 72201635S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-05 |