MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-09 for NOIR TRANSSPHENOIDAL SPECULA 90X13MM FF590B manufactured by Aesculap Ag.
[116697700]
(b)(4). Manufacturing site evaluation: the decontaminated instruments are available for investigation. The outer threads of the screw have been examined and found to be according to the specifications as well as the inner threads of the legs of the instrument. The instrument is according to specifications. The device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to our valid specification at the time of production. No similar incidents have been filed with products from these batches. Based on the information available as well as a result of the ingestion the root cause of the failure is most probably related to an insufficient maintenance of the device. The instruments of the complaint is according to the specifications valid at the time of production.
Patient Sequence No: 1, Text Type: N, H10
[116697701]
Country of complaint: (b)(6). During the procedure, there was a temporary impairment of the nasal mucosa. The instrument could not be turned back together intraoperatively. The screw appeared to be damaged and would not allow the instrument to open and close. There appeared to be temporary damage of the patient's nasal mucosa that will heal fully and will most likely not negatively influence the patient in the future. All med watch submissions related to this report are: 9610612-2018-00350; 9610612-2018-00351 (this report); 9610612-2018-00352; 9610612-2018-00353.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00351 |
| MDR Report Key | 7770413 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-09 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-07-10 |
| Date Facility Aware | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2018-01-20 |
| Date Added to Maude | 2018-08-09 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOIR TRANSSPHENOIDAL SPECULA 90X13MM |
| Generic Name | INSTRUMENTS FOR NEUROSURGERY |
| Product Code | EPY |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-07-24 |
| Model Number | FF590B |
| Catalog Number | FF590B |
| Lot Number | 52394914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-09 |