MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-24 for ELITE SYSTEM M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE M3-30A manufactured by Gyrus Acmi, Inc. - Norwalk.
[1195338]
Two devices were used in this procedure, please see medwatch report # 1519132-2009-00006 for the second device. During a prostate surgery, the end of the scope and the tip of the sheath blew apart. Chips of beak were removed from the bladder and the prostate was burned. A new scope and a new sheath were used to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8332890]
The customer's observation was not confirmed. The investigation revealed that the distal end of the scope is severly burned. The burn damaged the optics and broke the seal, which allowed moisture into the scope. The burn damage was user error. Another device was also used in this procedure, medwatch report# 1519132-2009-00006 for an emrs-28b sheath. The distal tip of the sheath was broken into several pieces and had burn damage as well. The burn damage was user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2009-00005 |
| MDR Report Key | 1387717 |
| Report Source | 07 |
| Date Received | 2009-03-24 |
| Date of Report | 2009-03-04 |
| Date of Event | 2009-03-04 |
| Date Facility Aware | 2009-03-04 |
| Date Mfgr Received | 2009-03-06 |
| Device Manufacturer Date | 2008-10-15 |
| Date Added to Maude | 2010-02-05 |
| 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 | TERRENCE 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. - NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE SYSTEM M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Generic Name | M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Product Code | FBP |
| Date Received | 2009-03-24 |
| Returned To Mfg | 2009-03-09 |
| Model Number | M3-30A |
| Catalog Number | M3-30A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. - NORWALK |
| Manufacturer Address | NORWALK OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-24 |