MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-08 for RIGHT ANGLE 3.4 MM DIAMETER SCISSORS 8404.62 manufactured by Richard Wolf Medical Instruments Corp..
[20055499]
Pt undergoing knee arthroscopy when it was noted on tv screen that a minute foreign body was present. Upon examining equipment, found that a small piece distal to the hinge of angle scissors had broken off. The piece was present post-lat on x-ray. Unable to find or extract intra-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30531 |
| MDR Report Key | 30531 |
| Date Received | 1996-01-08 |
| Date of Report | 1995-09-07 |
| Date of Event | 1995-09-07 |
| Date Facility Aware | 1995-09-07 |
| Report Date | 1995-09-07 |
| Date Added to Maude | 1996-03-01 |
| 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 | 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 | RIGHT ANGLE 3.4 MM DIAMETER SCISSORS |
| Generic Name | SCISSORS |
| Product Code | HRR |
| Date Received | 1996-01-08 |
| Catalog Number | 8404.62 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31594 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORTE WOODS PKWY VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1996-01-08 |