MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-07 for SAFETY SCALPEL SM4511NS manufactured by S & S Surgical.
[142093173]
Root cause: the device is supplied to deroyal by s & s surgical. Therefore, a supplier corrective action request (scar) was issued to s & s surgical. In its response, the supplier stated that the root cause could not be determined. The machine is running normal, and inspection system is functioning properly. As per the label on the box, blades may become exposed during shipping. The physical sample is needed for further investigation. Corrective action: a corrective action has not been taken due to the root cause determination. Investigation summary: an internal complaint (call (b)(4)) was received indicating that a safety scalpel (finished good (b)(4)) was not fully retracted, resulting in an operator stabbing herself during packing. The actual sample was not available for return. However, photos were received that confirmed the reported event. Deroyal's investigator reviewed internal quality records for possible discrepancies. No discrepancies were identified. The 2016-2018 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. Similar complaints were identified. Therefore, a scar was issued to the supplier -- s & s surgical -- as well as photos of the reported event. The scar response was received february 22, 2019, and accepted by deroyal's complaint investigator. During a two-year period, deroyal has sold (b)(4) cases of the finished good. During this same time period, three complaints were received for the finished good. This equates to a complaint-to-sales ratio of (b)(4) percent. Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[142093174]
An operator stabbed herself during packing due to a non-retracted retractable scalpel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2019-00004 |
| MDR Report Key | 8401371 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-03-07 |
| 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 | 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 | 2019-03-07 |
| Model Number | SM4511NS |
| Lot Number | 013616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 26003 US 26003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |