MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-11-19 for KOH CUP KCP-35 KCP-35-2 manufactured by Coopersurgical Inc..
[236741]
During laparoscopically assisted vaginal hysterectomy, severe endometriosis was encountered. Physician had to convert to open surgery. The physician failed to remove the vaginal fornices delineator used in the laparoscopic assisted vaginal hysterectomy procedure. Pt returned to hosp on a later date claiming discomfort and delineator was removed from vaginal canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2001-00040 |
| MDR Report Key | 361590 |
| Report Source | 05,06 |
| Date Received | 2001-11-19 |
| Date of Report | 2001-11-19 |
| Date of Event | 2001-01-30 |
| Date Mfgr Received | 2001-10-23 |
| Date Added to Maude | 2001-11-29 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS WILLIAMS DIR. |
| Manufacturer Street | 15 FOREST PARKWAY |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2039296321 |
| 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 | VAGINAL FORNICES DELINEATOR |
| Product Code | HDM |
| Date Received | 2001-11-19 |
| Model Number | KCP-35 |
| Catalog Number | KCP-35-2 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 350746 |
| Manufacturer | COOPERSURGICAL INC. |
| Manufacturer Address | 15 FOREST PARKWAY SHELTON CT 06484 US |
| Baseline Brand Name | KOH CUP |
| Baseline Generic Name | VAGINAL FORNICES DELINEATOR |
| Baseline Model No | KCP-35 |
| Baseline Catalog No | KCP-35-2 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-19 |