MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-22 for 26-1221 manufactured by Codman & Shurtleff Inc..
[6075]
Perforator was checked by the scrub nurse and by the surgeon, prior to use on the patient. The skull perforator was then used on the patient and failed to stop cutting, penetrating the dura. The area was repaired with sutures. No further complications. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, mechanical tests performed. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8890 |
| MDR Report Key | 8890 |
| Date Received | 1994-07-22 |
| Date of Report | 1993-01-12 |
| Date of Event | 1992-12-22 |
| Date Facility Aware | 1992-12-22 |
| Report Date | 1993-01-12 |
| Date Reported to FDA | 1993-01-12 |
| Date Reported to Mfgr | 1993-01-06 |
| Date Added to Maude | 1994-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DISPOSABLE 14MM PERFORATOR WITH HUDSON END |
| Product Code | HGE |
| Date Received | 1994-07-22 |
| Catalog Number | 26-1221 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8551 |
| Manufacturer | CODMAN & SHURTLEFF INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-22 |