MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-14 for KOH CUP KCP-35 manufactured by Coopersurgical, Inc..
[1059434]
The koh/rumi colpotomizer system was initially to be used for a laparoscopic hysterectomy. After the start of the procedure, the case was converted to an open hysterectomy. The physician removed the manipulator, but the koh cup remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
[8181129]
The koh colpotomizer system is indicated for use in laparoscopic procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove or access intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision. The continued use of the koh colpotomizer system after switching to an open hysterectomy could be considered using the device contrary to its intended use. In keeping with good medical practice, it is the responsibility of the physician to ensure all non-implantable devices are removed from the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00001 |
| MDR Report Key | 1325466 |
| Report Source | 06 |
| Date Received | 2009-01-14 |
| Date of Report | 2009-01-14 |
| Date Mfgr Received | 2009-01-13 |
| Date Added to Maude | 2009-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOH CUP |
| Generic Name | COLPOTOMIZER SYSTEM |
| Product Code | HDM |
| Date Received | 2009-01-14 |
| Model Number | KCP-35 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-14 |