MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-25 for DIADUST MIC NDL HDL RD HDL HEAVY 230MM FM539R manufactured by Aesculap Ag.
[170080322]
Manufacturing site evaluation: investigation on-going. Additional information and investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[170080323]
It was reported that there was an issue with a needle holder. During the surgery the scissors and the needle holders opened at the hinge during handling; the needle holders did not close and open well, instrument made a creaking noise. The result was a tear of the mammary artery, which the surgeon was able to repair. Nothing fell into the surgical field. An additional medical intervention was necessary. Additional information was not provided nor available. It was unknown whether the instrument was tested prior to use. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00786 |
| MDR Report Key | 9372328 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-10-09 |
| Date Added to Maude | 2019-11-25 |
| 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 |
| 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, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | DIADUST MIC NDL HDL RD HDL HEAVY 230MM |
| Generic Name | SPECIALITIES CARDIO-THORACIC S |
| Product Code | HXK |
| Date Received | 2019-11-25 |
| Model Number | FM539R |
| Catalog Number | FM539R |
| 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 | 2019-11-25 |