MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-03-21 for EWEND SUCTION RING CURRETTE N090D5.0-160 manufactured by Bausch + Lomb.
[103100237]
Bausch + lomb contacted the user facility and requested additional information. The user facility declined to provide any additional medical details regarding the event. They also declined to return the device for product evaluation. Photographs of the device have been requested but not yet received. The results of the investigation are pending the receipt of the additional information.
Patient Sequence No: 1, Text Type: N, H10
[103100238]
A report was received through the fda voluntary report program stating that while a patient was undergoing a transsphenoidal hypophysectomy for a pituitary tumor, the ring curette instrument broke apart in the patients nasal cavity/brain tissue. The end of the curette separated from the handle at the distal attachment. The instrument was removed but the patient sustained a cerebrovascular event. The patient was intubated with poor prognosis until care was withdrawn.
Patient Sequence No: 1, Text Type: D, B5
[106069443]
A review of the complaint database found no other complaints have been received for this device in the past five years. Although the product was not returned, the user facility provided a photograph of the device. The photograph showed evidence of braze at the location of detachment. The presence of braze indicates the device was manufactured per specifications. The product was sold to the user facility in march 2014 and has not been returned for repair or as a complaint previous to this report. The cause of the reported problem could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001932402-2018-00003 |
| MDR Report Key | 7359214 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-03-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-03-21 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3845 CORPORATE CENTRE DRIVE |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EWEND SUCTION RING CURRETTE |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2018-03-21 |
| Model Number | N090D5.0-160 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-21 |