MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-20 for VM T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1 MM NL4252-81T / 2110814BT manufactured by S.u.a. Martin Gmbh &co.kg.
[112456586]
A deep dent in the cutting edge indicates that the instrument was used to cut hard material, such as wire. Evaluation is in progress. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[112456587]
The device broke while being used in the patient's neck during an acdf procedure. The broken piece of the device jaw fell into the neck and was retrieved with the suction and a forceps. There was no harm to the patient nor the doctor. The procedure was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010386-2018-00007 |
| MDR Report Key | 7619959 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2017-10-27 |
| Date Added to Maude | 2018-06-20 |
| 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 | 3 |
| Brand Name | VM T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1 MM |
| Generic Name | MANUAL RONGEUR |
| Product Code | HAE |
| Date Received | 2018-06-20 |
| Catalog Number | NL4252-81T / 2110814BT |
| Lot Number | L17XME |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-20 |