MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for CODMAN 26-1221 261221 manufactured by Codman & Shurtleff, Inc..
[181935848]
Codman perforator 14mm lot # j59k60 used with power midas rex legend perforator driver [serial number]. During the creation of the first burr hole, the codman perforator did not automatically stop once perforation of cranium was completed. The perforator became 'stuck' in cranium and had to be removed from driver. The perforator came apart in 3 pieces when surgeon tried to pull perforator out of cranium. After successfully removing all pieces, surgeon noted that only 'old' blood from subdural was seen. Open further inspection of the patient's brain, surgeon stated that brain appeared normal with no signs of perforation of brain tissue. Manufacturer response for codman perforator, codman (per site reporter). They filed a complaint on their end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9785417 |
| MDR Report Key | 9785417 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-21 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-04 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) |
| Product Code | HBF |
| Date Received | 2020-03-04 |
| Model Number | 26-1221 |
| Catalog Number | 261221 |
| Lot Number | J59K60 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |