MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-03 for KOH CUP KCP manufactured by Coopersurgical, Inc..
[2083160]
Rumi koh system utilized for attempted laparoscopic hysterectomy. Procedure was converted to open. Koh cup (cap) of uterine manipulator was retained after removal of the system. Found when pt presented with vaginal discharge. Pt returned to outpatient clinic with vaginal discharge. Upon exam it was determined that koh cup was not removed during hysterectomy. Pt was sedated and koh was removed vaginally in the outpatient setting.
Patient Sequence No: 1, Text Type: D, B5
[9013484]
The directions for use indicate the koh colpotomizer system will be removed during vaginal closure/laparoscopic closure along with the uterus and uterine manipulator. In keeping with good medical practice, the physician is responsible to ensure all non-implantable devices are removed from the pt. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2011-00010 |
| MDR Report Key | 2135073 |
| Report Source | 05 |
| Date Received | 2011-06-03 |
| Date of Report | 2011-05-31 |
| Date of Event | 2011-03-02 |
| Date Mfgr Received | 2011-05-19 |
| Date Added to Maude | 2011-06-23 |
| 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 | 2016015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOH CUP |
| Generic Name | COLPOTOMIZER SYSTEM |
| Product Code | HEX |
| Date Received | 2011-06-03 |
| Catalog Number | KCP |
| 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 | 2011-06-03 |