MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-10-03 for CYSTOURETHROSCOPE STANDARD OBTURATOR E121-O manufactured by Gyrus Acmi, Inc..
[3850816]
Gyrusacmi was notified via a uf medwatch that the plastic tip of the sheath device used in a cystoscopy procedure broke off and apparently fell into vaginal folds. Broken off plastic tip fell out of the pt a few hours after the procedure. No injury or additional procedure required for the pt.
Patient Sequence No: 1, Text Type: D, B5
[11276440]
At the time of this report, the device has not yet been returned for eval. As a result, a determination cannot be made at this time. If further info becomes available, guyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2013-00026 |
| MDR Report Key | 3466445 |
| Report Source | 00,06 |
| Date Received | 2013-10-03 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-08-18 |
| Date Mfgr Received | 2013-09-04 |
| Date Added to Maude | 2013-12-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. TERRANCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD. |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 93 NORTH PLEASANT ST. |
| Manufacturer City | NORWALK OH 44857 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYSTOURETHROSCOPE STANDARD OBTURATOR |
| Generic Name | CYSTOURETHROSCOPE STANDARD OBTURATOR |
| Product Code | FEC |
| Date Received | 2013-10-03 |
| Model Number | E121-O |
| Catalog Number | E121-O |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-03 |