MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-08 for MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM PE184A manufactured by Aesculap Ag.
[126658174]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[126658175]
It was reported by the healthcare professional to the company sales representative "the surgeon and tech could not get a good image through the scope. Per the account, they switched to the pedi version; towers, light cords, cameras, and monitors attempting to get a working image. Scope was not inserted into patient. The patient was not under anesthesia at the time, but the case was delayed while the team opened the other scope and got set up. " there was a 15 minute delay in surgery. No additional intervention needed. No serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00496 |
| MDR Report Key | 8052881 |
| Report Source | OTHER |
| Date Received | 2018-11-08 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-10-12 |
| Date Facility Aware | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2018-11-08 |
| 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 | 3 |
| Brand Name | MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM |
| Generic Name | NEUROENDOSCOPY |
| Product Code | GWG |
| Date Received | 2018-11-08 |
| Model Number | PE184A |
| Catalog Number | PE184A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-08 |