MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-09 for M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG M3-30A manufactured by Gyrus Acmi, Inc.
[174466548]
As part of our investigation, multiple follow ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained. In addition, the telescope was not returned to the service center for evaluation. Therefore, the cause of the reported event cannot be determined at this time. However, if additional information becomes available, or if the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[174466549]
On december 17, 2019 the manufacturer received medwatch report (mw5091350) that states, "during cystoscopy procedure, room staff noted they smelled something burning and patient moaned in pain so cystoscopy scope was removed. The end of the scope was blackened and scope body also had lighter colored black marks on shaft. This scope was used with an olympus light cable and a karl storz light source. This report is for 1 of 2 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00309 |
| MDR Report Key | 9571369 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-01-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG |
| Generic Name | AUTOCLAVABLE FOROBILQUE TELESCOPE |
| Product Code | FAS |
| Date Received | 2020-01-09 |
| Model Number | M3-30A |
| 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 | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-09 |