MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for OPTHALMIC CRYO SYSTEM DIG CE-2000 manufactured by Coopersurgical, Inc..
[75171280]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75171281]
(b)(4). "shock from the on/off switch from the cryo machine to the left hand. Mild numbness to hand and tingling for a few minutes. " follow up 05/11/2017: "the electronic screen was blank, after turning on the cryo machine. Cryo was not preformed due to not being able to know the temperature. When turning the black lever to off on the frigitronics box, it send a shock to my left hand. My hand was mildly numb and tingly for about 5 mins afterwords. "
Patient Sequence No: 1, Text Type: D, B5
[87007720]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is complete, a follow up report will be filed. (b)(4). **update 06/12/2017** investigation: inspect returned samples. *analysis and findings a review of the 2 yr complaint history reveals no similar issues. A review of the dhr is not available but not expected to reveal relevant information. This unit was manufactured in november 2010. The unit was received and evaluated by service and repair. The complaint condition could not be duplicated and the unit functioned to specifications. The complaint was not confirmed. The unit's power is two 9 v batteries that had arrived depleted. The overall condition of the casing was very good including its rubber feet. The root cause for this complaint condition is not available and not related to the device. The occurrence of a shock to the end user is likely due to the particular conditions present at the end user's location, but the ce-2000 was not the source of the shock. *correction and/or corrective action the unit was checked over and found to function to specifications. This complaint will be entered into the coopersurgical continuous improvement plan (cip).
Patient Sequence No: 1, Text Type: N, H10
[87007721]
(b)(4). "shock from the on/off switch from the cryo machine to the left hand. Mild numbness to hand and tingling for a few minutes. " follow up (b)(6) 2017: "the electronic screen was blank, after turning on the cryo machine. Cryo was not preformed due to not being able to know the temperature. When turning the black lever to off on the frigitronics box, it send a shock to my left hand. My hand was mildly numb and tingly for about 5 mins afterwards. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00030 |
| MDR Report Key | 6562851 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2010-12-30 |
| Date Added to Maude | 2017-05-12 |
| 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. NANA BANAFO |
| Manufacturer Street | 75 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 | 3 |
| Brand Name | OPTHALMIC CRYO SYSTEM DIG |
| Generic Name | OPTHALMIC CRYO SYSTEM DIG |
| Product Code | HQA |
| Date Received | 2017-05-12 |
| Returned To Mfg | 2017-04-24 |
| Model Number | CE-2000 |
| Catalog Number | CE-2000 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-12 |