MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-08 for HERC III 360 001-401-160 N/A manufactured by Terumo Cardiovascular Systems Corp..
[66866471]
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66866472]
The user facility reported to terumo cardiovascular that the arm stabilizer is broken. It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery. Due to the unknown information for this event, it is being reported. Terumo continues to attempt to gain more information regarding this event from the user facility.
Patient Sequence No: 1, Text Type: D, B5
[71752076]
This follow-up report is submitted to fda in accord with applicable regulations? And as indicated by terumo cardiovascular systems in the initial report submitted to the fda on february 8, 2017. The sample was not returned for evaluation, and no details of the event were provided; therefore, a complete investigation was not able to be conducted and the complaint was not confirmed as a definitive root cause was not able to be determined. No details of the event were provided; therefore, the actual failure mode of the device is unknown, and possible root causes are not able to be considered. As the hercules arm is a reusable device, and it was reported that the arm broke, it is possible that the arm was damaged during re-use or re-processing. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124841-2017-00021 |
| MDR Report Key | 6312770 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-08 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2014-09-29 |
| Date Added to Maude | 2017-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS CATHLEEN HARGREAVES |
| Manufacturer Street | 125 BLUE BALL ROAD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERC III 360 |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | DWB |
| Date Received | 2017-02-08 |
| Model Number | 001-401-160 |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Brand Name | HERC III 360 |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | MSW |
| Date Received | 2017-02-08 |
| Model Number | 001-401-160 |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-08 |