MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-08-28 for KOH CUP manufactured by .
[8155478]
The koh colpotomizer system was used in tandem with a robotic surgical system. The koh colpotomizer system has not been indicated for use with a robotic surgical system. In keeping with good medical practice, it is the responsibility of the physician to ensure all non-implantable devices are removed from the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00029 |
| MDR Report Key | 1312947 |
| Report Source | 00 |
| Date Received | 2008-08-28 |
| Date Mfgr Received | 2008-08-18 |
| Date Added to Maude | 2009-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2008-08-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-28 |