MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-02-23 for SAFETY SCALPEL SM45SCNS manufactured by S & S Surgical.
[68217810]
Root cause: the true root cause has been determined to be a customer-related shipping issue. The scalpels are shipped per the customer's specifications. The customer provided photographs that indicate the packaging and the product sustained damage during shipping. Corrective action: deroyal will continue to monitor this issue. In an e-mail, the customer indicated it has revised its pallet dimensions for product shipments. Investigation summary: an internal complaint (call (b)(4)) was received reporting that, when unpacking boxes of the product, the safety scalpel blades were not fully retracted, which presented a risk. This report is not being filed within 30 days of deroyal becoming aware of the event. As part of the investigation, a retrospective review of complaints was conducted and this report was identified as being related to reports 1060680-2017-00001 and 1060680-2017-00005. The initial report indicated that a sample was available for return. As of the date of this report, a sample has not been received. However, the customer provided photographs. These photographs confirm the reported issue but also indicate the packaging and the product sustained damaged during shipping. Deroyal ships the product per the customer's specifications. The safety scalpel is supplied to (b)(6). Therefore, a supplier corrective action request to (b)(6). As of the date of this report, a response has not been received. Preventive action: a preventive action has not been taken. 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
[68217811]
During the unpacking of boxes, it became evident that the blades were not fully retracted and therefore could have caused serious injury to the persons unpacking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00006 |
| MDR Report Key | 6352801 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2016-12-01 |
| Date Added to Maude | 2017-02-23 |
| 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 | 2017-02-23 |
| Model Number | SM45SCNS |
| Lot Number | 9932 |
| Device Availability | Y |
| 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 | 2017-02-23 |