MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for SERVICE REP CONTROL UNIT ASSEMBLY 7205841S manufactured by Smith & Nephew, Inc..
[95539669]
Patient Sequence No: 1, Text Type: N, H10
[95539670]
It was reported by customer that device presented a unknown failure during procedure with no back up device available. No patient injuries or complications reported.
Patient Sequence No: 1, Text Type: D, B5
[137137443]
A visual inspection was performed on the product and no issue was observed. There was no relationship found between the returned device and the reported incident. Complaint of a functional failure could not be confirmed. Control unit passed functional testing and 2 hour burn-in using 3 different types of hand pieces. Control unit also passed functional testing with and without a known good footswitch installed. All functions perform as expected. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2017-01836 |
| MDR Report Key | 7134180 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2017-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SERVICE REP CONTROL UNIT ASSEMBLY |
| Generic Name | STERILIZER, SOFT-LENS, THERMAL, AC-POWERED |
| Product Code | HRX |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2017-12-26 |
| Catalog Number | 7205841S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Brand Name | SERVICE REP CONTROL UNIT ASSEMBLY |
| Generic Name | STERILIZER, SOFT-LENS, THERMAL, AC-POWERED |
| Product Code | HRD |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2017-12-26 |
| Catalog Number | 7205841S |
| 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 | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |