MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for MINOP INVENT 30DG TROCAR D8.3MM L150MM FH620R manufactured by Aesculap Ag.
[81142075]
(b)(4). Manufacturing site evaluation:evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[81142076]
Country of complaint; (b)(6). A piece of the black coating was sheared off and landed in the patient. The case had to be stopped while the coating was removed. Unknown how long the length of time the case was delayed. Components in use listed as concomitant devices are: fh620r / minop invent 30dg trocar d8. 3mm l150mm. Gk360r / minop bipolar fork electrode 2. 1mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00377 |
| MDR Report Key | 6742358 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-07-02 |
| Date Facility Aware | 2017-07-20 |
| Date Mfgr Received | 2017-07-03 |
| Device Manufacturer Date | 2017-04-04 |
| Date Added to Maude | 2017-07-25 |
| 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 |
| 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 | 0 |
| Brand Name | MINOP INVENT 30DG TROCAR D8.3MM L150MM |
| Generic Name | CRANIAL NEUROENDOSCOPY SYSTEMS |
| Product Code | GWG |
| Date Received | 2017-07-25 |
| Returned To Mfg | 2017-07-21 |
| Model Number | FH620R |
| Catalog Number | FH620R |
| Lot Number | 52324797 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 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. Other | 2017-07-25 |