MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID RB9344 / 10138 manufactured by S.u.a. Martin Gmbh &co.kg.
[107705016]
The photographs supplied by the user show considerable device damage: the tip was bent and the blade had broken off. When used in accordance with its intended use, the device cannot break. The device was apparently damaged due to misuse or rough handling, such as falling to the ground. Manufacturing records, including acceptance testing records, were checked for the lot in question and found to be conforming. No similar complaints have been received for this device. The root cause of the damage cannot be established since the device is not available for inspection and testing.
Patient Sequence No: 1, Text Type: N, H10
[107705017]
During use, the tip of the device is reported to have broken and fallen into the patient's brain cavity. The surgeon retrieved the broken tip from the patient. A 15-minute delay of the surgery occurred. Surgery was completed with other instruments and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010386-2018-00004 |
| MDR Report Key | 7477385 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2018-05-01 |
| 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 | MR. MARKUS PAULI |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78604 |
| Manufacturer G1 | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | YARARGIL MICRO DISSECTOR BAYO 7-1/4 ARACHNOID |
| Generic Name | MICRO DISSECTORS |
| Product Code | GZX |
| Date Received | 2018-05-01 |
| Catalog Number | RB9344 / 10138 |
| Lot Number | 100180-1608 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Address | UHLANDSTRASSE 17 RIETHEIM-WEILHEIM, 78604 GM 78604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-01 |