MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-21 for SAFETY SCALPEL D4511A manufactured by S & S Surgical.
[129324652]
Root cause: the root cause was determined to be lack of complete training by individuals processing the scalpels. Personnel ensured the blades were not protruding but did not verify the scalpels were in a locked position. This allowed some of the scalpels that appeared locked to maneuver open during transit. Corrective action: all applicable personnel will be reinstructed on the packaging process. Deroyal will continue to monitor reports received for the product and take additional action necessary to eliminate the issue in the future. Investigation summary: an internal complaint (b)(4) was received indicating that the blade of a safety scalpel (part d4511a, lot 48078481) was protruding when the package was opened. A sample was initially reported to be available, but this sample was not returned to deroyal for evaluation. However, a photograph of the reported defect was provided and confirmed that a blade was not secured inside the scalpel handle. Finished good inventory was checked for loose or exposed blades. No issues were found. The locking mechanisms of all the scalpels that were checked were found to be functioning correctly prior to shipping. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The scalpel is supplied to deroyal by s & s surgical. However, the reported event was determined not to be a malfunction or defect of the scalpel but the result or an error that occurred during the packaging process. Therefore, the manufacturer was not notified of the event. Preventive action: due to the corrective action taken, a preventive action is not required at this time. 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
[129324653]
Blade is not secure in scalpel and is sticking out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2018-00011 |
| MDR Report Key | 8096468 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-21 |
| 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 | 1595 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 | 2018-11-21 |
| Model Number | D4511A |
| Lot Number | 48078481 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-21 |