MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-10 for EXPLORA CURETTE 3MM WITH MX120 manufactured by Coopersurgical, Inc..
[92804594]
(b)(4). Investigation: *analysis and findings: the described event cannot be fully determined if it refers to the slider site marker that is snapped onto the cannula, or the on the barrel syringe that engages with the plunger for a certain amount of travel within the barrel. Both are assembled and packaged at csi trumbull, but each plays a separate roll and they're both functionally verified for acceptability. The slider marker is intended to be used as a depth marker as it's description implies, and is designed to move with minimal applied force. The syringe lock prevents the plunger from being fully deployed at a predetermined volume marking. Without the actual device being returned for investigative analysis, a defined root cause cannot be defined and therefore considered indeterminable. Based on the limited event information provided, it's likely that the reported event was the result of use contra to ifu instruction for use. However, if the device is returned in the future, the complaint may be reopened and addressed as needed. Review of the dhr has indicated that all manufacturing and assembly instructions were follow, no abnormalities were found. All lot inventory has been depleted and no longer available for further review. Corrective actions: *correction and/or corrective action: corrective action is not applicable due to the absence of the actual affected device for investigative analysis as it was not returned, to determine a possible root cause. Reason: per (b)(4), this complaint will be monitored for trending in that no injury was reported to end user or patient. *was the complaint confirmed? No.
Patient Sequence No: 1, Text Type: N, H10
[92804595]
*what are the details of the complaint? Is there anything else? The doctor was doing a procedure, but the stopper did not stop and inserted itself into the patient. The syringe and the curette performed correctly only the stopper. *was there any additional medical attention? They will retrieve the stopper during the already scheduled surgery (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00067 |
| MDR Report Key | 7022469 |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2017-11-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DR |
| 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 | EXPLORA CURETTE 3MM WITH |
| Generic Name | EXPLORA CURETTE 3MM WITH |
| Product Code | HHK |
| Date Received | 2017-11-10 |
| Model Number | MX120 |
| Catalog Number | MX120 |
| Lot Number | 204002 |
| Device Expiration Date | 2019-10-14 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DR TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-11-10 |