MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-11-10 for YASARGIL CLIP 586008 manufactured by Medicon E.g..
[128627007]
The clip brace was slightly bent and had broken near one end. Closing pressure and closing function were found to be within specifications. The bent brace and the traces of blood found on the clip indicate improper handling during the surgical procedure. Apparently force was applied to the clip by another object, first bending and finally breaking the brace.
Patient Sequence No: 1, Text Type: N, H10
[128627008]
During a surgical procedure, undue force seems to have been applied to the clip with a foreign object, leading to breakage. The patient did not suffer any harm. No further information has been provided by the distributor, who first indicated that the malfunction occurred during use of the device, and then that it broke during cleaning and sterilization prior to first use. The second statement does not hold, since the returned device showed traces of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010099-2018-00004 |
| MDR Report Key | 8058035 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-10 |
| Date of Report | 2018-11-10 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2017-10-17 |
| Date Added to Maude | 2018-11-10 |
| 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 | ANTON MITTERMUELLER |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | MEDICON E.G. |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL CLIP |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2018-11-10 |
| Catalog Number | 586008 |
| Lot Number | O314650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICON E.G. |
| Manufacturer Address | GAENSAECKER 15 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-10 |