MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-11-16 for VISUAL URETHROTOME SHEATH EVUS-22 manufactured by Gyrus Acmi, Inc..
[1810130]
During a procedure while using the visual urethrotome sheath, the unit was bent while in pt. The surgeon removed it without any pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8826573]
Visual inspection of the instrument confirms that the shaft is bent approx 2" to 3" from the distal end. Also noted are minor dents along the shaft. Tube thickness was measured and meets the mfg requirements. The bend profile in the sheath tube suggests application of excessive lateral force was exerted on the instrument by the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2010-00038 |
| MDR Report Key | 1914342 |
| Report Source | 06 |
| Date Received | 2010-11-16 |
| Date of Report | 2010-11-16 |
| Date of Event | 2010-11-05 |
| Date Facility Aware | 2010-11-05 |
| Date Mfgr Received | 2010-11-05 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2012-02-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| 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 | VISUAL URETHROTOME SHEATH |
| Generic Name | VISUAL URETHROTOME SHEATH |
| Product Code | EZO |
| Date Received | 2010-11-16 |
| Returned To Mfg | 2010-11-08 |
| Model Number | EVUS-22 |
| Catalog Number | EVUS-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-11-16 |