MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for YASARGIL TI TEMP MINI-CLIPSTRNARR 3MM FT180T manufactured by Aesculap Ag.
[101255799]
(b)(4). Manufacturing site evaluation: a complaint was received about malfunctions of three different kinds of temporary aneurism clips. The products are not available for investigation, but a video of the surgery has been provided. There was a 15 minute surgery delay. The product is not available for investigation. According to the statement of the responsible product manager of the marketing department, the used forceps is not an aesculap application forceps. Clips must be used only with the appropriate size of applying or removing forceps. The device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to oem specifications valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage. According to the ifu the clip must be used only with the appropriate size of applying or removing forceps. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[101255800]
(b)(6). Clips didn't close correctly so that the vessel has bled further. The sister had to rinse again and again to get a better view. No information about the lot number. All clips, which are ordered for the surgery normally are prepared without package in one box for the surgeon. Surgery delay: 20 minutes, no further consequences for the patient. Components in use listed as concomitant devices are: ft180t / yasargil ti temp mini-clipstrnarr 3mm, ft182t / yasargil ti temp minislt-cvdnarr2. 8mm, ft200t / yasargil ti temp mini-clip str 3mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00083 |
| MDR Report Key | 7301098 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-01-16 |
| Date Facility Aware | 2018-02-15 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-27 |
| 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 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 | YASARGIL TI TEMP MINI-CLIPSTRNARR 3MM |
| Generic Name | YASARGIL TITANIUM ANEURYSM CLIPS TE |
| Product Code | HCH |
| Date Received | 2018-02-27 |
| Model Number | FT180T |
| Catalog Number | FT180T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2018-02-27 |