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 2019-01-08 for AVM MICROCLIP PHYNOX STR.3MM STERILE FE953K manufactured by Aesculap Ag.
[133048095]
(b)(4). Manufacturing site evaluation: the implant arrived in decontaminated form with visible damage. Investigation: investigation was carried out visually with a camera and microscopically. The jaw was opened and the clip was no longer in its delivery state; there were also some material "quirks" noted. Batch history review: the device quality and manufacturing batch history records have been checked and found to be within specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause is most probably usage related. Rationale: according to the quality standards and dhr files, a material defect and production error can be excluded. The clips are subject to a 100% inspection and a delivery condition with poor geometry is excluded. Investigations lead to the assumption that the opened jaws and "quirks" were caused by improper handling. There is the possibility of incorrect gripping with the applying forceps and thus opening too wide with the forceps; or they were caused by using an applier or removal forceps from another manufacturer. Therefore, there is a restriction of functionality and possible change to the closing force. The clip was not distributed in this condition. The factory-set closing force could no longer be tested because the clip was no longer in its delivery state. Furthermore, the ifu cautions that certain points must be observed. According to the ifu, damage may occur to the avm microclip due to incorrect handling, restriction of the functionality and changing of the closing force. The microclip must only be removed and applied with the aesculap-avm applying forceps. Damage to the avm microclip may occur from it slipping out of place, breaking or snapping out. The clip must be carefully grasped with the aesculap-avm applying forceps and removed.
Patient Sequence No: 1, Text Type: N, H10
[133048096]
It was reported that there was an issue with the cerebrovascular clip during surgery. The sterile package was opened during the procedure and the clip was inserted into the applicator forceps without any problems. However, when closure of the clip was attempted, it failed to close properly and was not released. Another clip was used instead to successfully complete the procedure. There was no harm to the patient noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00002 |
| MDR Report Key | 8227962 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-12 |
| Date Facility Aware | 2018-12-18 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2018-06-06 |
| Date Added to Maude | 2019-01-08 |
| 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 | 3 |
| Brand Name | AVM MICROCLIP PHYNOX STR.3MM STERILE |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2019-01-08 |
| Returned To Mfg | 2018-12-19 |
| Model Number | FE953K |
| Catalog Number | FE953K |
| Lot Number | 52435901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| 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 | 2019-01-08 |