MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for SAFETY SCALPEL D4511A manufactured by S & S Surgical.
[123950783]
Root cause: a definitive root cause has not been determined. However, the following possible root causes have been identified: the outside processor did not ensure the scalpel was locked in place before packaging into the poly bag or the scalpel was exposed to force during shipping that caused the handle to unlock and the blade to become exposed. Corrective action: packaging and labeling personnel were notified of the reported issue. Investigation summary: an internal report (call (b)(4)) was received indicating a safety scalpel (part d4511a) contained a blade that was loose and not secure inside the scalpel. The customer returned five cases (500 eaches) for evaluation. All five cases were opened and inspected. Of the 500 eaches, one blade was seen protruding from a scalpel handle. The locking mechanism of this scalpel as well as 19 others were checked, and all were found to be functioning correctly. Additionally, all five cases were seen to have a sticker on the box stating they were "released. " a review of the device history record showed no discrepancies related to the reported issue. Raw material and finished good inventory found no inventory with loose or exposed blades. The scalpels are supplied to deroyal be s & s surgical. The complaint investigator did not notify the supplier of the reported issue because the investigator determined the exposed blade was not a malfunction or defect of the scalpel. The locking mechanisms of the raw material scalpels were checked and all were found to be functioning correctly. An outside operation packages the scalpels into poly bags, closes the bags with twist ties, and places these bags into individual boxes to be shipped to deroyal. This outside operation was notified of the reported issue as well as personnel at deroyal's manufacturing facility where inspection is performed. Deroyal has sold (b)(4) cases or (b)(4) eaches of the finished good from september 2016 to present. During this same period, a total of six complaints (including this one) were received for this product. This equates to 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. The investigation is complete at this time. If new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[123950784]
The blade was loose, not secured inside the scalpel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2018-00006 |
| MDR Report Key | 7957473 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-10-11 |
| 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 | 0 |
| Brand Name | SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2018-10-11 |
| Returned To Mfg | 2018-10-04 |
| Model Number | D4511A |
| Lot Number | 47535838 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-11 |