MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-05-19 for #11 SAFETY SCALPEL D4511A manufactured by S &s Surgical Products, Inc..
[45578343]
Root cause: the reported issue has been determined to be an attention-based error by the end user. Deroyal provides instructions for use with the device and within the directions for use section are specific instructions for product use. Corrective action: a corrective action has not been taken. Investigation summary: an internal complaint (b)(4) was received indicating that the reporting customer is having issues with a safety scalpel (finished good d4511a, lot number 40418006). According to the customer's report, the scalpel operated differently than the user expected and opened into the palm. As a result, the clinician sustained a laceration. Deroyal supplies instructions for use with the product. Under the directions for use, instructions are provided for handling and usage of the device. Step 2 states, "grasp the scalpel and carefully extend the blade by moving the blue slide toward the tip of the scalpel, using the thumb of the hand holding the scalpel. " the design of the product clearly identifies the direction of the blade and movement of the slider. One end of the red handle is closed and the other opened so the blade can extend. When retracted, the blue slider is positioned toward the closed end of the handle. In this position, the slider can only move upward toward the opened end of the handle to extend the blade. Deroyal has sold (b)(4) each of finished good d4511a from 2014 to present. During this same period, (b)(4) complaints were received for scalpel sticks or cuts. This is a complaint-to-sales ratio of (b)(4) percent. Deroyal will continue to monitor post market feedback and will recognize in the future if a trend develops. Preventive action: due to the investigation and root cause, a preventive action has not been taken. The investigation is complete. If new and critical information is received, this report will be updated. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[45578345]
The scalpel opened differently than the user expected and opened into the palm of the hand. The clinician sustained a laceration that broke the skin and required 5 minutes of compression to stop the bleeding. The injury was washed and a light compression bandage applied. The laceration healed after a few days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004605321-2016-00002 |
| MDR Report Key | 5667182 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-04-19 |
| Date Added to Maude | 2016-05-19 |
| 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 | KM 7 AUTOPISTA JOAQUIN BALAGUE PISANO FREE ZONE, BUILDING 49 |
| Manufacturer City | SANTIAGO, SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | #11 SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2016-05-19 |
| Catalog Number | D4511A |
| Lot Number | 40418006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S &S SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 333 DEMENT RD. TRIADELPHIA WV 26059 US 26059 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |