MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for YASARGIL PERM STD-CLIP SLT-CVD 13.7MM FE782K manufactured by Aesculap Ag.
[28329704]
Manufacturing site evaluation is on-going.
Patient Sequence No: 1, Text Type: N, H10
[28329745]
Country of complaint: (b)(6). Customer requesting review and confirmation of closing force of clips. It was reported that the closing force was too weak during bypass surgery; clip being temporarily used during the collection of graft. One surgery was referenced, however (4) fe762k and (2) fe782k were received for evaluation. Not reported which product(s) were used during mentioned surgery. Related to medwatch 2916714-2015-00901.
Patient Sequence No: 1, Text Type: D, B5
[34227756]
(b)(4). Manufacturing site evaluation: reference code 2 x fe782k, 4 x fe762k. Device name yasargil clip std. Permanent. Serial number (b)(4) (fe782k), (b)(4) (fe762k). Batch number 51951441, 51989192 (fe782k). 51807166 (fe762k). Manufacturing date 07/16/2013, 12/16/2013 (fe782k). 01/18/2012 (fe762k). The products were analyzed by microscope. The products show incorrect jaw positions and gaps between the jaw parts. The device history report was reviewed to review the closing force at the time of release. The device quality and manufacturing history records were reviewed for all available lot numbers. The device history file has been checked and found to be according to specification valid at the time of production. Based on the information available as well as a result of the investigation, the root cause of the failure is most likely user related. According to the statement of the surgeon, these type of clips are for permanent use only. The incorrect position and the gap in the jaw is an indication that the jaw was opened more than once which may cause a deviation of the closing force. Closing force can not be guaranteed after several openings. This is clearly indicated in the ifu. Based on the investigation and the statistical analysis manufacturing errors and a design related root cause are excluded. Error is likely user related. No additional action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00902 |
| MDR Report Key | 5140790 |
| Date Received | 2015-10-09 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-07-31 |
| Date Mfgr Received | 2015-08-02 |
| Device Manufacturer Date | 2013-07-16 |
| Date Added to Maude | 2015-10-09 |
| 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 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 PERM STD-CLIP SLT-CVD 13.7MM |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2015-10-09 |
| Model Number | FE782K |
| Catalog Number | FE782K |
| Lot Number | 51951741 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2015-10-09 |