MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-16 for ANDERSON-ADSON SCALP RETRACTOR 50-1186 manufactured by Symmetry Surgical Inc..
[5867889]
Retractor ratchet mechanism broke during surgery, patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
[13373735]
Device was sent back to symmetry, missing the ratchet piece that broke off, symmetry could not perform an evaluation on the device. This device was manufactured in 2004 by codman - no further history other than age of device is more than 10 years. Other devices in-warehouse stock were reviewed, all functioned properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2015-00013 |
| MDR Report Key | 4862050 |
| Report Source | 06 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-03-17 |
| Date Facility Aware | 2015-03-17 |
| Report Date | 2015-06-15 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2015-06-26 |
| 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 | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANDERSON-ADSON SCALP RETRACTOR |
| Generic Name | RETRACTOR |
| Product Code | GZT |
| Date Received | 2015-06-16 |
| Returned To Mfg | 2015-04-13 |
| Model Number | 50-1186 |
| Catalog Number | 50-1186 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-16 |