MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for STERILE 3.5 ULTEM KOH-EFF AD750-KE35 manufactured by Coopersurgical, Inc..
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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
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(b)(4). Fda report mw5068804. "the coopersurgical uterine delineator/manipulator has had 3 events where sparking traveling from the blue ring to the center of the manipulator tip has occurred and witnessed by the surgical staff. The manipulator itself does not connect to any sort of cautery, but only serves as a tool to move the uterus for the case and, by design, as a guide to cut the uterus and cervix away from the top of the vagina. No harm to any patients. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00027 |
| MDR Report Key | 6555091 |
| Date Received | 2017-05-09 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-05-09 |
| 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 |
| 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 | 0 |
| Brand Name | STERILE 3.5 ULTEM KOH-EFF |
| Generic Name | STERILE 3.5 ULTEM KOH-EFF |
| Product Code | HEW |
| Date Received | 2017-05-09 |
| Model Number | AD750-KE35 |
| Catalog Number | AD750-KE35 |
| Lot Number | 182-16 |
| Device Expiration Date | 2017-07-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2017-05-09 |