MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-26 for BLAKESLEY THRUBITE FORCEPS 335801 manufactured by Gyrus Medical Gmbh.
[2534170]
Pt was undergoing a transsphenoidal resection of a pituitary tumor. During surgery the nasal forcep broke off inside the pt. Both pieces were retrieved and there was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[9623375]
Device not returned as of (b)(4) 2012. No injury reported. No other complaints for this part number in 2 years. Originally reported by user facility, report (b)(4). Originally reported as part number 23-0728, however, when contacted to investigate the user facility stated that was an error and the actual part number is 335801.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2012-00001 |
| MDR Report Key | 2443658 |
| Report Source | 06 |
| Date Received | 2012-01-26 |
| Date of Report | 2012-01-26 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2012-01-03 |
| Date Added to Maude | 2012-08-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DOLAN MILLS |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS MEDICAL GMBH |
| Manufacturer Street | GOTENSTR 3 |
| Manufacturer City | TUTTLINGEN D-78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKESLEY THRUBITE FORCEPS |
| Product Code | KAE |
| Date Received | 2012-01-26 |
| Catalog Number | 335801 |
| Lot Number | 03055663/HX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL GMBH |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-26 |