MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for STERILE 3.5 SOFT KOH-EFF AD750SC-KE35 manufactured by Coopersurgical, Inc..
[136994953]
Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136994954]
(b)(4). Coopersurgical has determined the condition reported (on (b)(6) 2018) : "this was sample product that was used in a case this morning at medical city plano. Upon completion of the case, it was discovered that the cup had been damaged during colpotomy stage of procedure. Surgeon stayed superficial to tissue during colpotomy using mono-polar robotic scs, however melting/lacerations to cup must have occurred when sc tips made contact with cup. No patient injury, and nothing was deposited or left in patient. " to be a reportable malfunction, based on the cumulative investigation of this failure mode on- (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00016 |
| MDR Report Key | 8311305 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-02-06 |
| 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 | STERILE 3.5 SOFT KOH-EFF |
| Generic Name | STERILE 3.5 SOFT KOH-EFF |
| Product Code | HEW |
| Date Received | 2019-02-06 |
| Model Number | AD750SC-KE35 |
| Catalog Number | AD750SC-KE35 |
| Lot Number | 227-18 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-06 |