MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES 110035 manufactured by Lsi Solutions, Inc.
[102742874]
Lsi received medwatch form # mw5075034 from cdrh on (b)(6) 2018. On (b)(6) 2018, lsi reached out to cdrh via email in an attempt to obtain information regarding the user facilty contact information associated with the event. Cdrh infomred lsi that the original report contained all of the releasable information available and that they would not be providing any additional information. Without any additional information regarding the user facitliy or obtaining the device in question, lsi is unable to investigate this event any further. The event will be captured in the lsi complaint system as complaint number (b)(4), for trending purposes. No other actions will be taken in regard to this event. If additional information is received or if the device is returned, lsi will reopen and further investigate the event.
Patient Sequence No: 1, Text Type: N, H10
[102742875]
Light cord became dislodged from fornisee device, which resulted in a burned drape. This event meets the joint commission of an operating room fire, and could have resulted in a permanent injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320468-2018-00001 |
| MDR Report Key | 7343479 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-09-30 |
| Date Added to Maude | 2018-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MELISSA CONLEY |
| Manufacturer Street | 7796 VICTOR MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal | 14564 |
| Manufacturer Phone | 5857845859 |
| Manufacturer G1 | LSI SOLUTIONS, INC. |
| Manufacturer Street | 7796 VICTOR-MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14564 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES |
| Generic Name | CULDOSCOPE AND ACCESSORIES |
| Product Code | HEW |
| Date Received | 2018-03-15 |
| Model Number | 110035 |
| Lot Number | 692269 |
| Device Expiration Date | 2019-09-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC |
| Manufacturer Address | 7796 VICTOR MENDON ROAD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-15 |