MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for COLPO-PNEUMATIC OCCLUDER CPO-6 manufactured by Coopersurgical, Inc..
[130789294]
This is the event as reported by operating room staff. Upon relief report, rn showed to me that part of the colpo pneumo device (plastic) was missing and a raytec was burned during the procedure. Dr. Obgyn checked vaginal cavity and said the plastic part is not inside the patients' vaginal cavity. Nothing was saved from the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8178215 |
| MDR Report Key | 8178215 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-12-07 |
| Report Date | 2018-12-18 |
| Date Reported to FDA | 2018-12-18 |
| Date Reported to Mfgr | 2018-12-19 |
| Date Added to Maude | 2018-12-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | COLPO-PNEUMATIC OCCLUDER CPO-6 |
| Generic Name | CULDOSCOPE |
| Product Code | HEW |
| Date Received | 2018-12-19 |
| Model Number | CPO-6 |
| Catalog Number | CPO-6 |
| Lot Number | 226773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |