MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for STERILE 4.0 ULTEM KOH-EFF AD750-KE40 manufactured by Coopersurgical, Inc..
[138932737]
Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138932738]
Arcing occurred on koh cup during colpotomy with monopolar cutting (settings 35-40 cut).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00127 |
| MDR Report Key | 8416465 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2019-03-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERILE 4.0 ULTEM KOH-EFF |
| Generic Name | STERILE 4.0 ULTEM KOH-EFF |
| Product Code | HEW |
| Date Received | 2019-03-13 |
| Model Number | AD750-KE40 |
| Catalog Number | AD750-KE40 |
| Lot Number | 075-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-13 |