MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-01 for INVISIO DIGITAL CONTROLLER WITH DVI IDC-1500 manufactured by Gyrus Acmi, Inc..
[2969063]
It was reported that during a ureteroscopy procedure using the digital fiberoptic scope. The ccu stopped midway through the procedure and the hosp had to procedure another controller from new hampshire to complete the procedure. The pt was awakened from anesthesia as it took 1 1/2 hours to procure the new controller. The pt was placed back under anesthesia and the procedure was completed with no further problems or harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10273249]
The customer's complaint of the instrument not working was unconfirmed. The eval of the returned idc-1500 found the scope has an older software version of 4. 20. 7 installed. The scope ran connected with the test dur-d for one hour with no indication of loss of image.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004356764-2012-00001 |
| MDR Report Key | 2770178 |
| Report Source | 06 |
| Date Received | 2012-10-01 |
| Date of Report | 2012-08-29 |
| Date of Event | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Date Added to Maude | 2013-01-17 |
| 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 | 0 |
| 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. |
| Manufacturer Street | 300 STILLWATER AVE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISIO DIGITAL CONTROLLER WITH DVI |
| Generic Name | INVISIO DIGITAL CONTROLLER WITH DVI |
| Product Code | KQM |
| Date Received | 2012-10-01 |
| Returned To Mfg | 2012-09-04 |
| Model Number | IDC-1500 |
| Catalog Number | IDC-1500 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 300 STILLWATER AVE STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-01 |