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 2017-05-15 for HERCULES III 001-401-161 N/A manufactured by Terumo Cardiovascular Systems Corp..
[75103394]
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). Results: results pending completion of evaluation. Conclusions: conclusion not yet available-evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[75103395]
The user facility reported to terumo cardiovascular that the item was locked up. It won't turn, the ball part of it was stuck. 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
[130061849]
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 may 15, 2017. Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer); (indication that this is a follow-up report); (follow-up due to additional information); (identification of evaluation codes 3317, 213, 67, 92). The sample was not returned for evaluation; therefore, the event was not confirmed. Based on the complaint description that handle was locked into place, it is likely that the handle of the arm was not able to tighten the arm into place, leaving it loose. It is possible for damage to have been caused to the hercules arm through use or re-processing, causing the handle to not move as freely as desired. It is also possible that the difficulty in turning of the handle is due to insufficient lubrication of the handle threads. 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 | 1124841-2017-00081 |
| MDR Report Key | 6566276 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-15 |
| Date of Report | 2017-06-20 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-05-15 |
| 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 | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | DWB |
| Date Received | 2017-05-15 |
| Model Number | 001-401-161 |
| Catalog Number | N/A |
| Lot Number | 72357 |
| 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 | HERCULES III |
| Generic Name | UNIVERSAL STABILIZER ARM |
| Product Code | MSW |
| Date Received | 2017-05-15 |
| Model Number | 001-401-161 |
| Catalog Number | N/A |
| Lot Number | 72357 |
| 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 | 2017-05-15 |