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 |