MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for DISP.UNIV-SEALING UNIT F/10/12MM TROCARS EK002SU manufactured by Aesculap Ag.
[138276612]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138276613]
It was reported by the healthcare professional "during the surgery the device started to leak air. The surgery was restarted after the device was replaced. The leakage occurred at the sealing unit. " additional patient information has been requested. When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00162 |
| MDR Report Key | 8395792 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-02-13 |
| Date Facility Aware | 2019-04-22 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-03-06 |
| 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 | 0 |
| Brand Name | DISP.UNIV-SEALING UNIT F/10/12MM TROCARS |
| Generic Name | DISPOSABLE TROCARS |
| Product Code | OKX |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-02-27 |
| Model Number | EK002SU |
| Catalog Number | EK002SU |
| Lot Number | 52476608 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-06 |