MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-10 for SAFETY SCALPEL SM4511NS manufactured by S & S Surgical.
[119812686]
Root cause: the scalpel is supplied to deroyal by s&s surgical. Therefore, a supplier corrective action request was issued to the supplier. In its response, the manufacturer indicated a root cause could not be determined because defective samples were not available for evaluation. Corrective action: a corrective action has not been taken. Investigation summary an internal complaint (call (b)(4)) was received indicating that, when unpacking boxes of a product (finished good (b)(4)), the scalpel blades were not fully retracted, creating a danger to staff. The investigator reviewed the purchase order for possible discrepancies. No discrepancies were identified. The scar and supplier notification letter logs were reviewed for similar complaints during the time period of 2015-2017. Similar complaints were identified and a scar was issued to the supplier as well as photos of the reported malfunction. A response to the scar has been received. From (b)(6) 2017 to (b)(6) 2018, deroyal has sold (b)(4) cases of the affected finished good. Each case contains (b)(4) each, which equates to a total of (b)(4) each sold. Two similar complaints were identified for this part number, which results in 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 recurs. Preventive action: a preventive action has not been taken. This report is being submitted outside the 30 day requirement due to employee oversight. 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
[119812687]
During unpacking and inspection, it was noticed that four blades were not fully retracted. This could have caused serious injury to the person removing the blades.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2018-00005 |
| MDR Report Key | 7860040 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-10 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-09-10 |
| 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 | 2018-09-10 |
| Model Number | SM4511NS |
| Lot Number | 012789 |
| 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 | 2018-09-10 |