MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-05 for SAFETY SCALPEL SM45SCNS manufactured by S & S Surgical Products.
[64266796]
Investigation summary an internal complaint ((b)(4)) was received reporting that, when unpacking boxes of the product, the safety scalpel blades were not fully retracted, which presented a risk. The initial report indicated that a sample was available for return. As of the date of this report, the sample has not been received. However, a photo has been made available and confirms the reported issue. The safety scalpel is supplied to deroyal by (b)(4). Therefore, a supplier corrective action report was issued to (b)(4). A response is due january 20, 2017. As of the date of this report, it has not been received. The investigation is incomplete at this time. When new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[64266797]
During the unpacking of the boxes, the blades were not fully retracted, causing danger to the staff.
Patient Sequence No: 1, Text Type: D, B5
[67884536]
Root cause: the scalpels are supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was issued to (b)(4). In its response, (b)(4) stated it was unable to determine the root cause. The initial reporter did not provide a lot number or a sample. However, a photo confirmed the reported issue. Deroyal has determined a potential root cause of a shipping-related issue. Corrective action: in its scar response, (b)(4) stated it will continue to review the process. Deroyal has put the raw material on incoming inspection and will inspect the next the shipment received for the reported issue. Investigation summary an internal complaint ((b)(4)) was received reporting that, when unpacking boxes of the product, the safety scalpel blades were not fully retracted, which presented a risk. The initial report indicated that a sample was available for return. As of the date of this report, the sample has not been received. However, a photo has been made available and confirms the reported issue. The safety scalpel is supplied to deroyal by (b)(4). Therefore, a supplier corrective action report was issued to (b)(4). A response was received january 13, 2017, and accepted january 20, 2017. Preventive action: a preventive action has not been taken.
Patient Sequence No: 1, Text Type: N, H10
[67884537]
During the unpacking of the boxes, the blades were not fully retracted, causing danger to the staff.
Patient Sequence No: 1, Text Type: D, B5
[68626589]
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 additional 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 ((b)(4)) was received reporting that, when unpacking boxes of the product, the safety scalpel blades were not fully retracted, which presented a risk. The initial report indicated that a sample was available for return. As of the date of this report, the sample has not been received. However, a photo has been made available and confirms the reported issue. Additional photographs from the customer were provided that indicate the packaging and the product sustained damage during shipping. Deroyal ships the product per the customer's specifications. The safety scalpel is supplied to deroyal by s&s surgical. Therefore, a supplier corrective action report was issued to s&s surgical. A response was received january 13, 2017, and accepted january 20, 2017. 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
[68626590]
During the unpacking of the boxes, the blades were not fully retracted, causing danger to the staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00001 |
| MDR Report Key | 6226981 |
| Date Received | 2017-01-05 |
| Date of Report | 2017-02-23 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| Date Added to Maude | 2017-01-05 |
| 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 | ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| 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 | 2017-01-05 |
| Model Number | SM45SCNS |
| Lot Number | NOT PROVIDED |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S & S SURGICAL PRODUCTS |
| Manufacturer Address | 117 EDGINGTON LANE WHEELING WV 26003 US 26003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |