MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for CE-2000 OPTHALMIC CRYO SYSTEM DIG manufactured by Coopersurgical, Inc..
[145512162]
(b)(4). Was the complaint confirmed? No. Investigation: x-inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals similar issues. This unit was manufactured under (b)(4) on 10/28/2008. Service & repair found the unit operated to specifications. The high pressure regulator was noted to be set at the low pressure end of the allowable range, approximately 420 psi. The complaint noted the unit would not defrost/thaw. Based on the ifu, a retinal probe should be operated with a pressure range of 600 - 625 psi. Too low a setting on the high pressure regulator will result in no thawing and the probe will not get to temperature. The customer may have changed to the pressure setting after getting the probe tip to freeze (at 600 psi). The unit is not designed to change on its own. A user needs to adjust the pressure up or down. Guidance on what pressures to use are in the ifu (page 10 of ifu p/n 38687) and on the cover label, p/n 34032 affixed to each and every unit. This unit was found to be set outside the recommended pressure setting for a retinal probe. Root cause for this complaint is being attributed to end user error. Correction and/or corrective action: none. Reason: no applicable correction available to train to at this time. The unit was confirmed to operate to specifications, set to the proper pressure setting and returned to the customer. This complaint will be entered into the coopersurgical continuous improvement plan (cip).
Patient Sequence No: 1, Text Type: N, H10
[145512163]
Review of repair order log (b)(4). Customer stated "probe would not thaw, froze to surgeons hand and patients eye". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00053 |
| MDR Report Key | 8522594 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2018-11-07 |
| Device Manufacturer Date | 2008-10-28 |
| Date Added to Maude | 2019-04-17 |
| 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 |
| 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 | 2019-04-17 |
| Model Number | 2000 |
| Catalog Number | 2000 |
| Lot Number | 100805 |
| 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 | 2019-04-17 |