MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for CURVED METZENBAUM SCISSORS BC606R manufactured by Aesculap Ag.
[141762489]
Patient presenting for right knee pain, difficulty walking for 12 months ago after fall where he hyperflexed his knee when falling. Since then has been unable to extend knee. No numbness/weakness. He was found to have full thickness quad tendon tear on mri and therefore indicated for reconstruction with allograft given the chronic nature of his injury. Given the patient's age, as well as his inability to ambulate given pain and extensor mechanism dysfunction, he was indicated for right quadriceps tendon repair with allograft. During surgical repair, scissors broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8508344 |
| MDR Report Key | 8508344 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-22 |
| Report Date | 2019-04-05 |
| Date Reported to FDA | 2019-04-05 |
| Date Reported to Mfgr | 2019-04-12 |
| Date Added to Maude | 2019-04-12 |
| 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 |
| 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 | CURVED METZENBAUM SCISSORS |
| Generic Name | GENERAL-PURPOSE SURGICAL SCISSORS, REUSABLE |
| Product Code | LRW |
| Date Received | 2019-04-12 |
| Model Number | BC606R |
| Catalog Number | BC606R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2019-04-12 |