MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-02-05 for YASARGIL TI PERM MINI-CLIP BAYO 4MM FT727T manufactured by Aesculap Ag & Co. Kg.
[16462073]
Country of complaint: (b)(6). The surgeon placed the clip and made a puncture to dome. After placement it was noticed that the tip of the blade was slightly scissored. Clip was left in patient as is.
Patient Sequence No: 1, Text Type: D, B5
[16812744]
Us reporting agent notified on 01/30/2015. Manufacturing site evaluation: we received no product, because the clip is still placed inside the patient. It could be possible, that the surgeon, due to an overload situation in the delicate jaw area a scissoring, had created. This product is 100% inspected during the final inspection. The blade alignment is inspected by a visual inspection. So we can exclude a manufacturing error. There are no other cases with "clip was left in patient with scissoring" in our system. Reviewed the manufacturing file of batch 52034072, the quality records as well as the production documents comply with our specifications and do not present any discrepancies. No other similar incidents have been declared concerning this batch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00083 |
| MDR Report Key | 4544163 |
| Report Source | 01,07 |
| Date Received | 2015-02-05 |
| Date of Report | 2015-02-05 |
| Date of Event | 2014-12-02 |
| Date Mfgr Received | 2014-12-02 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-03-24 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI PERM MINI-CLIP BAYO 4MM |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2015-02-05 |
| Model Number | FT727T |
| Catalog Number | FT727T |
| Lot Number | 52023072 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-05 |