MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-18 for MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM FF399R manufactured by Aesculap Ag.
[142462442]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[142462443]
It was reported that there was an malfunction of the minop device. During pre-incision testing, the surgeon noted that the overflow channel was not receiving outflow. The patient was on the operating room and prepped when it occurred; however, the first incision had not been made. The originally planned surgery was an endoscopic third ventriculostomy. The surgical team worked to try and solve the issue for about an hour, which delayed the start of the surgery. Also, due to the malfunction of the neuro-endoscopy device, the surgeon decided to perform a shunt insertion instead. The outcome of the procedure was not noted; the minop system was never used on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00273 |
| MDR Report Key | 8529719 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-18 |
| Date of Report | 2019-07-05 |
| Date of Event | 2019-03-29 |
| Date Facility Aware | 2019-03-29 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-04-18 |
| 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. KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, MO 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM |
| Generic Name | NEUROENDOSCOPY |
| Product Code | GWG |
| Date Received | 2019-04-18 |
| Model Number | FF399R |
| Catalog Number | FF399R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-04-18 |