MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-19 for SAFETY SCALPEL SM45SCNS manufactured by S & S Surgical.
[73246317]
An internal complaint ((b)(4)) was received reporting that the blade of a safety scalpel (part number sm45scns) was not fully retracted into the handle, thus creating risk for serious injury. A sample was not available for return. However, a photo of the reported failure was provided for evaluation. The scalpel is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request has been issued. As of the date of this report, the scar is still open. The investigation is ongoing. This report will be updated when new and critical information is received.
Patient Sequence No: 1, Text Type: N, H10
[73246318]
The safety scalpel blade is not fully retracted within the handle. This nearly resulted in an injury to a staff member. Loose blades also were found inside one of the inner bags. This was found during unpacking of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00012 |
| MDR Report Key | 6505327 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-19 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2017-04-19 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2017-04-19 |
| Model Number | SM45SCNS |
| Lot Number | 010633 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S & S SURGICAL |
| Manufacturer Address | 117 EDGINGTON LANE WHEELING WV 20063 US 20063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-19 |