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 2019-03-13 for VALVE XS DISS.SCISSORS 15?CVD.235/370MM FC370R manufactured by Aesculap Ag.
[138775716]
(b)(4). If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138775717]
It was reported the scissors malfunctioned intraoperatively. During a minimally invasive coronary artery bypass graft (cabg) procedure, while using a pair of scissors the blades started crossing too far and would get stuck. Per the reporter, both blades fall to the side occasionally as you operate the scissors. A second parif of scissors were used, which demonstrated the same issue. The surgery was reported to have taken a little longer due to obtaining a third pair of scissors from a different company to finish the case. No harm was done to the patient. No other information has been provided. Associated medwatches: 9610612-2019-00175.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00176 |
| MDR Report Key | 8418794 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-13 |
| Date of Report | 2019-06-08 |
| Date Facility Aware | 2019-05-09 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-10-05 |
| Date Added to Maude | 2019-03-13 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| 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 | VALVE XS DISS.SCISSORS 15?CVD.235/370MM |
| Generic Name | SPECIALITIES CARDIO-THORACIC S |
| Product Code | LRW |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-03-05 |
| Model Number | FC370R |
| Catalog Number | FC370R |
| Lot Number | 52440559 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-13 |