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 2016-09-23 for YASARGIL TI TEMP STD-CLIP STR 9MM FT250T manufactured by Aesculap Ag.
[55481740]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[55481741]
Country of complaint: (b)(6). It is reported that when removing the temporary clip from the carotid artery, using forceps, bleeding occurred.
Patient Sequence No: 1, Text Type: D, B5
[75233367]
Investigation: the clip was analyzed using a keyence vhx 5000 digital microscope. The measurement of the closing force was carried out in the production department, using scale id#(b)(4). The actual closing force is 96 gram and is thereby in the specific range of tolerance (90? 7 gram). The production department confirmed that the clip is in a normal condition, no deviations could be found at the clips, especially at the jaw parts. Batch history review: the device quality and manufacturing history records have been checked for the available lot number. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably user related. Rational: the clip is according to our specification, thus we exclude a manufacturing or a material error. Corrective action: according to sop sa-de13-m-4-2-01-010 a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2016-00800 |
| MDR Report Key | 5973637 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-23 |
| Date of Report | 2017-04-05 |
| Date of Event | 2016-09-01 |
| Date Facility Aware | 2016-09-06 |
| Date Mfgr Received | 2016-09-05 |
| Device Manufacturer Date | 2014-05-05 |
| Date Added to Maude | 2016-09-23 |
| 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 TI TEMP STD-CLIP STR 9MM |
| Generic Name | TEMPORARY CLIP |
| Product Code | HCH |
| Date Received | 2016-09-23 |
| Returned To Mfg | 2016-09-13 |
| Model Number | FT250T |
| Catalog Number | FT250T |
| Lot Number | 52028307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 28 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 | 1. Other | 2016-09-23 |