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..
[128263273]
The jaw of the clip was misaligned, which can only be caused by applying great external force to the jaw. Closing function was impaired. The state of the device indicates improper handling during the surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
[128263274]
Application of excessive force to the jaw part of the clip during a surgical procedure caused clip jaw misalignment and impaired clip function by making it impossible to close the clip properly. 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 was damaged 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 | 8010099-2018-00005 |
| MDR Report Key | 8058151 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-10 |
| Date of Report | 2018-11-10 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2016-07-27 |
| 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 | Q388286 |
| 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 |