MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,company representative, report with the FDA on 2015-06-03 for AVM MICROCLIP PHYNOX STRAIGHT 3MM FE903K manufactured by Aesculap, Inc..
[5902095]
Country of complaint: (b)(6). Product was not able to grasp a blood vessel because the blades of this product had gap. The product was scrapped at the hospital and not available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[13461149]
Mfr. Site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[69478100]
Manufacturing site evaluation: we received a complaint about an avm-clip fe903k, lot 52096238. The customer indicated that the product was not able to grasp a blood vessel because the blades of the product had a gap. The product was scrapped at the hospital and not available for investigation. The device quality and manufacturing history records have been checked for the available lot number. The device history file has been checked and were found to be according to the specification valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available it is not possible to determine root cause for the failure. It is most likely that the failure occured due to an overload situation during handling. These clips undergo a 100% inspection prior to release. A systematical design related root cause has been excluded based on the statistical analysis. Corrective/preventive action: not applicable.
Patient Sequence No: 1, Text Type: N, H10
[69773882]
Follow up 2: corrections: follow up 1 for this submission contained incorrect information in the following areas: has incorrect brand name: should be avm microclip phynox straight 3 mm. Common device name: should be aneurysm clip. Has incorrect model #, catalog #, and lot# : should be fe903, 52096238. These have been corrected on this follow up.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00450 |
| MDR Report Key | 4828264 |
| Report Source | 01,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-03 |
| Date of Report | 2017-03-07 |
| Date of Event | 2015-04-21 |
| Date Mfgr Received | 2015-04-30 |
| Date Added to Maude | 2015-06-23 |
| 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 | 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&CO KG |
| Manufacturer Street | P.O. 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 STRAIGHT 3MM |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2015-06-03 |
| Model Number | FE903K |
| Catalog Number | FE903K |
| Lot Number | 52096238 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-03 |