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 2019-04-17 for VALVE XS TC NEEDLEHOLDER STR.225/365MM FC275R manufactured by Aesculap Ag.
[142229114]
(b)(4). Preliminary investigation: the instrument is in used condition, one screw of the handle is missing. Investigation: a pictorial documentation visually and microscopically was carried out. The welded screw lock of one screw is broken and therefore the screw could loosen. The instrument has been forwarded to the manufacturer for further investigations. Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale: due to the circumstance, that the product has been sent to the manufacturer for investigation, this is a preliminary report and it will be updated after we received a statement from the manufacturer. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142229115]
It was reported the screws were loosening intraoperatively. The reporter indicated loosening of the screws on the needle holder occurred during a cardiovascular procedure. The issue was detected during the cleaning process. No additional patient information has been provided. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00250 |
| MDR Report Key | 8522721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date Facility Aware | 2019-04-05 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2015-10-19 |
| Date Added to Maude | 2019-04-17 |
| 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. 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 | VALVE XS TC NEEDLEHOLDER STR.225/365MM |
| Generic Name | SPECIALITIES CARDIO-THORACIC S |
| Product Code | HXK |
| Date Received | 2019-04-17 |
| Returned To Mfg | 2019-03-20 |
| Model Number | FC275R |
| Catalog Number | FC275R |
| Lot Number | 52167761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-17 |