MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-07 for SERV REPL, HD COUPLER, 19.5MM 72201635S manufactured by Smith & Nephew, Inc..
[59599939]
Patient Sequence No: 1, Text Type: N, H10
[59599940]
It was reported that the device had broken parts. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[62945223]
Review of the device history records were performed which confirmed no inconsistencies.
Patient Sequence No: 1, Text Type: N, H10
[96749516]
An evaluation was performed by the smith & nephew and could confirm the customer complaint for the devise having a broken part. A visual inspection was preformed and showed the coupler has been used in field. This device was shipped to the customer in 2011. The eyepiece is cracked exposing the o-ring. This is caused by hard contact to the eyepiece. No manufacturing related defects were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2016-00107 |
| MDR Report Key | 6084162 |
| Date Received | 2016-11-07 |
| Date of Report | 2017-07-05 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-11-07 |
| 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. JAMES GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DR. |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | 3 |
| Brand Name | SERV REPL, HD COUPLER, 19.5MM |
| Generic Name | INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE |
| Product Code | FEI |
| Date Received | 2016-11-07 |
| Catalog Number | 72201635S |
| Lot Number | BBB2125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-11-07 |