MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-31 for V. MUELLER NL 3785-010 manufactured by Carefusion.
[25109238]
A micro dissector tip broke off in side the surgical site. Doctor was able to locate and remove the broken tip. The tip and the instrument were immediately removed from the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055958 |
| MDR Report Key | 5057990 |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-19 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | V. MUELLER |
| Generic Name | V. MUELLER |
| Product Code | OCV |
| Date Received | 2015-08-31 |
| Model Number | NL 3785-010 |
| Catalog Number | NL 3785-010 |
| Lot Number | AIO |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | CHICAGO IL 60673 US 60673 |
| Brand Name | RHOTON HOOK 90 BLUNT |
| Generic Name | RHOTON HOOK 90 BLUNT |
| Product Code | GZX |
| Date Received | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-31 |