MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-13 for CE-2000 OPTHALMIC CRYO SYSTEM DIG manufactured by Coopersurgical, Inc..
[182791700]
Coopersurgical, inc. Is currently investigating the reported condition. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182791701]
"customer stated "all probes freezing. So cold it sticks to eye. Pressure gauge freezes over. Pressure gauge leaks". Reference repair order # (b)(4). Ref: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2020-00024 |
| MDR Report Key | 9705875 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2006-12-28 |
| Date Added to Maude | 2020-02-13 |
| 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 | 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 6015200334 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CE-2000 OPTHALMIC CRYO SYSTEM DIG |
| Generic Name | CE-2000 OPTHALMIC CRYO SYSTEM DIG |
| Product Code | HQA |
| Date Received | 2020-02-13 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | 120601 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |