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 2019-04-22 for YASARGIL TI PERM STD-CLIP BAYO 9MM FT758T manufactured by Aesculap Ag.
[144971552]
(b)(4). Investigation: the investigation was carried out visually and microscopically. Here we found no mal-aligned jaw or another failure. Additional we detected traces of usages. Furthermore, the implant was sent to the quality assurance of the production department for a closing force test. The closing force has been examined with the check weigher for clip id (b)(4). According to specification (1. 96 n +/- 7. 5 % (min. 2. 107 n, max. 1. 813)) is the closing force in the allowable tolerance with 1. 88 n. In addition, the complaint could not be reconstructed with scissoring. Batch history review: the device quality and manufacturing history records have been checked for the lot number (52126145) and found to be according to the specification, valid at the time of production. No similar incidents have been filed with products from this batch conclusion and root cause: no failure was found. Rationale: due to our investigation no failure was found. According to the quality standard and to the dhr files a production error and a material defect can be excluded. Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded. According to the report of the quality assurance of the production department the instrument complies with our specifications. No capa necessary.
Patient Sequence No: 1, Text Type: N, H10
[144971553]
It was reported the clip jaw was maligned intraoperatively. The reporter indicated the surgeon loaded the clip on the applier, but before approaching the aneurysm neck, it was noticed that the blades of the clip were not aligned with each other ("like scissoring"). Per the reporter, the clip was taken from the original sterile package. The clip was replaced with a new clip from a different batch number. There was no harm to the patient. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00260 |
| MDR Report Key | 8537886 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Facility Aware | 2019-04-08 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2015-04-17 |
| Date Added to Maude | 2019-04-22 |
| 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 BAYO 9MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-05 |
| Model Number | FT758T |
| Catalog Number | FT758T |
| Lot Number | 52126145 |
| 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 | 2019-04-22 |