MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-08-11 for CRANIAL ACCESS SINGLE STERILE HAND DRILL * 030 manufactured by Clinical Neuro Systems.
[321664]
The cranial access drill in the kits is breaking at the handle during a ventrix procedure. No patient injury was reported but the procedure required a new drill to be used. This has been occurring for the last 1 1/2 months. The kit numbers were ins-7040 from lot numbers d03012 and b01056.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028223-2003-00011 |
| MDR Report Key | 477619 |
| Report Source | 05,06,07 |
| Date Received | 2003-08-11 |
| Date of Report | 2003-08-11 |
| Date Mfgr Received | 2003-07-16 |
| Date Added to Maude | 2003-08-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | CLINICAL NEURO SYSTEMS |
| Manufacturer Street | 309 COMMERCE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIAL ACCESS SINGLE STERILE HAND DRILL |
| Generic Name | CRANIAL ACCESS |
| Product Code | HBG |
| Date Received | 2003-08-11 |
| Model Number | * |
| Catalog Number | 030 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 466425 |
| Manufacturer | CLINICAL NEURO SYSTEMS |
| Manufacturer Address | 309 COMMERCE DR. EXTON PA 19341 US |
| Baseline Brand Name | CRINIAL ACCESS SINGLE STERILE HAND DRILL |
| Baseline Generic Name | CRINIAL ACCESS |
| Baseline Model No | * |
| Baseline Catalog No | 030 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-11 |