MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-27 for ACUFEX 012036 * manufactured by Acufex S&n Endo.
[400125]
During an arthroscopic knec surgery, a piece of the arthroscopic scissor punch broke off. The surgeon was able to retrieve the broken piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 617192 |
| MDR Report Key | 617192 |
| Date Received | 2005-06-27 |
| Date of Report | 2005-06-13 |
| Date of Event | 2005-06-10 |
| Date Facility Aware | 2005-06-13 |
| Report Date | 2005-06-14 |
| Date Reported to FDA | 2005-06-14 |
| Date Reported to Mfgr | 2005-06-14 |
| Date Added to Maude | 2005-06-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX |
| Generic Name | ARTHROSCOPIC SCISSOR PUNCH |
| Product Code | HRR |
| Date Received | 2005-06-27 |
| Model Number | 012036 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 606894 |
| Manufacturer | ACUFEX S&N ENDO |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-06-27 |