MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2012-10-22 for BLADE TRITON 8MM GRAFT HARVEST 238GH1SS manufactured by Mdt Powered Surgical Solutions.
[3091183]
It was reported that "there was an incident today (b)(6) where doctor asked for a 8mm and ended up taking a 6mm graft not knowing. I do not know the extent the packaging played on this but i do know there was confusion and he had to take a second graft. " no patient impact reported. No additional information was available upon follow up.
Patient Sequence No: 1, Text Type: D, B5
[10251409]
Report confirmed. Visual examination of an example of the packaging determined that the description, containing the size of the blade, was not reflected on the current packaging. Gcapa (b)(4) was opened on (b)(6) 2012 to address this issue. Instructions included in device user manual states, "prior to each use, the entire triton" power surgical instrument system must be inspected for proper operation". We will continue to track and trend this complaint type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625507-2012-00102 |
| MDR Report Key | 2798173 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2012-10-22 |
| Date of Report | 2012-09-19 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-19 |
| Date Added to Maude | 2012-10-22 |
| 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 | DAVID LEERS |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal | 761373291 |
| Manufacturer Phone | 8177886587 |
| Manufacturer G1 | MEDTRONIC POWERED SURGICAL SOLUTIONS |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 761373291 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLADE TRITON 8MM GRAFT HARVEST |
| Generic Name | SAW, POWERED, AND ACCESSORIES |
| Product Code | KFK |
| Date Received | 2012-10-22 |
| Catalog Number | 238GH1SS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 N BEACH ST FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-22 |