MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-10 for COOPER SURGICAL UNK manufactured by Cooper Surgical.
[35339965]
During surgical procedure, tip of aspiration needle broke off after insertion through trocar. Physician able to retrieve needle with grasper. No adverse outcome. Procedure: left ovarian cytology. Mfr ref #1216677-2004-00013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5350315 |
| MDR Report Key | 5350315 |
| Date Received | 2004-09-10 |
| Date of Report | 2004-07-29 |
| Date of Event | 2004-07-28 |
| Date Facility Aware | 2004-07-28 |
| Report Date | 2004-07-29 |
| Date Reported to Mfgr | 2004-07-30 |
| Date Added to Maude | 2016-01-07 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOPER SURGICAL |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | HFC |
| Date Received | 2004-09-10 |
| Catalog Number | UNK |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-10 |