MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-22 for MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM PE184A manufactured by Aesculap Ag.
[133791671]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[133791672]
During a ventriculotomy procedure the surgeon was attempting to use a zero degree scope. It was reported the scope could not focus enough to execute what needed to be done to complete the procedure. This caused a delay in surgery and the surgery was re-scheduled. The surgical site was opened and the patient was under anesthesia when this occurred. Additional information has been requested regarding the patient outcome and the re-scheduled procedure. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00010 |
| MDR Report Key | 8268795 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-12-18 |
| Date Facility Aware | 2018-01-17 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-22 |
| 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 | MRS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM |
| Generic Name | CRANIAL NEUROENDOSCOPY SYSTEMS |
| Product Code | GWG |
| Date Received | 2019-01-22 |
| Model Number | PE184A |
| Catalog Number | PE184A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-22 |