MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-24 for DEROYAL SAFETY SCALPEL COMPONENT OF TRAY 89-7387 manufactured by Merit Medical.
[17414157]
During surgery, as the surgeon moved the scalpel blade toward the scrub table, while pressing the button to retract the blade, the blade ejected from the scalpel housing. Hospital claims blade ejected with a lot of force. There was no injury to any surgical personnel or the pt.
Patient Sequence No: 1, Text Type: D, B5
[17753172]
During surgery, as the surgeon moved the scalpel blade toward the scrub table, while pressing the button to retract the blade, the blade ejected from the scalpel housing. Hosp claims blade ejected with a lot of force. There was no injury to any surgical personnel or the pt. Deroyal industries, inc is the mfr of the angiography tray but the safety scalpel involved in this report is mfg by merit medical. The safety scalpel is a component of the deroyal angiography tray. Several samples of different safety scalpels from different lots did not produce any blade retraction malfunctions when tested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005011024-2012-00001 |
| MDR Report Key | 2559993 |
| Report Source | 05,06 |
| Date Received | 2012-04-24 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-02-25 |
| Date Mfgr Received | 2012-03-29 |
| Date Added to Maude | 2012-09-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | MERIT MEDICAL |
| Manufacturer Street | 1600 WEST MERIT PKWY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL SAFETY SCALPEL COMPONENT OF TRAY |
| Generic Name | SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2012-04-24 |
| Returned To Mfg | 2012-03-29 |
| Model Number | 89-7387 |
| Lot Number | 24271355 |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL |
| Manufacturer Address | SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-24 |