MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for CE82 DELIVERY SYSTEM 1216677-2000 2000 manufactured by Coopersurgical, Inc..
[141462319]
Coopersurgical, inc. Is investigating the condition reported on repair order log (b)(4). Ref: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141462320]
Review of repair order log (b)(4). "provider states knobs extremely difficult to turn guage does not work correctly all of the time, has not been serviced in at least 6 years". While "trying to do cryo retinopexy" and the "procedure had not begun". There was "no" patient injury, "no" additional medical attention. Additionally customer stated the following : -was there a potential health risk? "yes"; "patient could have lost vision". Ref (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00051 |
| MDR Report Key | 8496790 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-09 |
| Date of Event | 2018-11-29 |
| Date Added to Maude | 2019-04-09 |
| 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 | 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 | CE82 DELIVERY SYSTEM |
| Generic Name | CE82 DELIVERY SYSTEM |
| Product Code | HQA |
| Date Received | 2019-04-09 |
| Model Number | 1216677-2000 |
| Catalog Number | 2000 |
| Lot Number | 079006 |
| 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 | 2019-04-09 |