MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for CE-2000 OPTHALMIC CRYO SYSTEM DIG manufactured by Coopersurgical, Inc..
[132578201]
The complaint condition reported is currently under investigation. A follow-up report will be filed once the investigation has been completed and the findings are available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132578202]
Per customer's statement on repair authorization form "probe pops of due to unwanted pressure. Pressure knob on back does not increase or decrease pressure". Reference repair order: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00092 |
| MDR Report Key | 8209188 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2017-03-22 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CE-2000 OPTHALMIC CRYO SYSTEM DIG |
| Generic Name | CE-2000 OPTHALMIC CRYO SYSTEM DIG |
| Product Code | HQA |
| Date Received | 2019-01-02 |
| Model Number | CE-2000 |
| Catalog Number | CE-2000 |
| Lot Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-02 |