MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-29 for ARTHREX TRIMANO FORTIS 100230R0 manufactured by Holger Ullrich.
[146399108]
At the time of this report the investigation was still ongoing. As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146399109]
It was reported that the handle of the trimano fortis was sticky. That is why the trimano arm was stuck during a surgery and could not be moved. After depressing the handle for several minutes it started to work again. The surgery proceeded and was completed after a 15 minute delay with the same product. No patient injury was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2019-00016 |
| MDR Report Key | 8650923 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-29 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2018-12-15 |
| Date Added to Maude | 2019-05-29 |
| 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 Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer G1 | HOLGER ULLRICH |
| Manufacturer Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX TRIMANO FORTIS |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2019-05-29 |
| Model Number | 100230R0 |
| Catalog Number | 100230R0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLGER ULLRICH |
| Manufacturer Address | MAQUET GMBH KEHLER STRASSE 31, RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-29 |