MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for KOH-EFFICIENT,RUMI,3.5CM KC-RUMI-35 manufactured by Coopersurgical, Inc..
[111441384]
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
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Medwatch mw5077295. "a couple of very small pieces of the blue coating on the rumi cup were found to have come off the device and were in the patient's abdomen during a robotic assisted total laparoscopic hysterectomy. The pieces were retrieved and the device removed from the patient. No adverse effects were noted and the patient was discharged home later that day. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00028 |
| MDR Report Key | 7593317 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-10 |
| Device Manufacturer Date | 2018-02-20 |
| Date Added to Maude | 2018-06-12 |
| 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 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 | KOH-EFFICIENT,RUMI,3.5CM |
| Generic Name | KOH-EFFICIENT,RUMI,3.5CM |
| Product Code | HEW |
| Date Received | 2018-06-12 |
| Model Number | KC-RUMI-35 |
| Catalog Number | KC-RUMI-35 |
| Lot Number | 243276 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-12 |