MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-17 for YASARGIL TI PERM STD-CLIP STR 7MM FT740T manufactured by Aesculap Ag.
[123969806]
(b)(4). Manufacturing site evaluation: the implant arrived in a clean status without visible damage. The components have been examined visually and microscopically with the digital microscope and the digital camera. A visual inspection of the clip was performed. Grooves and quirks were found. Traces of usage and unknown deposits were found. Furthermore the implant was sent to the quality assurance of the production department for closing force test. The closing force has been examined with the check weighed for clip id (b)(6). The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification and valid at the time of production. No similar incidents have been filed with products from this batch. The root cause of the product is most probably usage related. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[123969807]
It was reported by the healthcare professional to the company sales representative "5 day po, (b)(6) 2018 the aneurysm clip turned perpendicular to the original placement during recovery and the patient needed to be sent back to surgery for another clip. There was a piece retrieval and replacement with another clip on (b)(6) 2018. " no patient injury reported. No delay in surgery reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00462 |
| MDR Report Key | 7973732 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-07-13 |
| Date Facility Aware | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Device Manufacturer Date | 2014-09-22 |
| Date Added to Maude | 2018-10-17 |
| 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 | YASARGIL TI PERM STD-CLIP STR 7MM |
| Generic Name | YASARGIL TITANIUM ANEURYSM CLIPS PE |
| Product Code | HCH |
| Date Received | 2018-10-17 |
| Returned To Mfg | 2018-08-14 |
| Model Number | FT740T |
| Catalog Number | FT740T |
| Lot Number | 52062069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| 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. Required No Informationntervention | 2018-10-17 |