MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for KCS-RUMI-30 manufactured by Coopersurgical, Inc..
[123674307]
Coopersurgical inc. Is currently investigating the reported complaint condition. The actual device involved in the complaint is expected to be returned for evaluation by customer. Once the investigation is completed a follow-up will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123674308]
"robot assisted hysterectomy - the device has broken during the procedure, and the broken part (the cup) was stuck in the patient's vagina. Risk of perforation. The procedure has been stopped. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00056 |
| MDR Report Key | 7960656 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-10-11 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2018-10-12 |
| 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 |
| 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 |
| 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 | KCS-RUMI-30 |
| Generic Name | KCS-RUMI-30 |
| Product Code | HEW |
| Date Received | 2018-10-12 |
| Model Number | KCS-RUMI-30 |
| Catalog Number | KCS-RUMI-30 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-10-12 |