MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-06-28 for USA ELITE CYSTOURETHROSCOPE STANDARD OBTURATOR E121-O manufactured by Circon Acmi.
[16360577]
Reportedly, during a tvt (transvaginal tape), the tip of the obturator fell off into the bladder and disintegrated into several pieces. Some of the fragments were removed "using a second cystoscope. " and the remaining fragments (too small to be picked out with a clip) were removed by checking and filtering the pt's urine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2001-00052 |
| MDR Report Key | 341430 |
| Report Source | 05,06 |
| Date Received | 2001-06-28 |
| Date of Report | 2001-06-28 |
| Date of Event | 2001-03-28 |
| Date Added to Maude | 2001-07-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY PICKARD |
| Manufacturer Street | 300 STILLWATER AVE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033288721 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE CYSTOURETHROSCOPE STANDARD OBTURATOR |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2001-06-28 |
| Returned To Mfg | 2001-06-12 |
| Model Number | E121-O |
| Catalog Number | E121-O |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 330767 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST NORWALK OH 448570409 US |
| Baseline Brand Name | OBTURATOR 21FR |
| Baseline Generic Name | 500 |
| Baseline Model No | E121-O |
| Baseline Catalog No | E121-O |
| Baseline ID | NA |
| Baseline Device Family | U1210 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-28 |