MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-10-06 for USA ELITE SYSTEM M3 AUTOCLAVABLE TELESCOPE M3-30A manufactured by Circon Acmi.
[169182]
Devices were returned by sales rep with a request for review. There was no indication of pt involvement. However, after a review of repair records, it was determined that the problem is a reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218764-2000-00011 |
| MDR Report Key | 300225 |
| Report Source | 07 |
| Date Received | 2000-10-06 |
| Date Mfgr Received | 2000-07-17 |
| Device Manufacturer Date | 2000-05-01 |
| Date Added to Maude | 2000-10-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY PICKARD |
| Manufacturer Street | 300 STILLWATER AVE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033280872 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE SYSTEM M3 AUTOCLAVABLE TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | ENZ |
| Date Received | 2000-10-06 |
| Returned To Mfg | 2000-07-17 |
| Model Number | M3-30A |
| Catalog Number | M3-30A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 290586 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 300 STILLWATER AVE. STAMFORD CT 06904 US |
| Baseline Brand Name | USA ELITE M3 AUTOCLAVABLE FOROBLIQUE TELESCOPE |
| Baseline Generic Name | TELESCOPE |
| Baseline Model No | M3-30A |
| Baseline Catalog No | M3-30A |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-06 |