MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-02 for HERCULES III T401161 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[112992882]
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
[112992883]
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the distal end of the hercules arm is sharp and abrasive which caused an abrasion in the heart while doing the procedure. There was a about a 15 minute delay to repair the abrasion. The procedure was completed successfully using the same arm as it was fixed by putting a seal on the unit. *no blood loss, *product was not changed out, *procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[121056042]
This follow-up report is submitted to fda in accord with applicable regulations. The returned sample was visually inspected upon receipt, and the investigation verified damage to the distal end of the hercules iii arm where the attachments are connected. A retention sample is not applicable for this is an individually serialized and released for distribution. All hercules universal stabilizer arms are visually inspected for damage prior to release; therefore, it is likely that the unit was exposed to a shock force after manufacturing that caused the abrasive edge. It was not able to be determined how or when the damage occurred. 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 | 1124841-2018-00130 |
| MDR Report Key | 7656811 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-02 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-07-02 |
| 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 | MS. CATHLEEN HARGREAVES |
| Manufacturer Street | 125 BLUE BALL ROAD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| 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 | DTZ |
| Date Received | 2018-07-02 |
| Returned To Mfg | 2018-07-03 |
| Model Number | T401161 |
| Catalog Number | N/A |
| Lot Number | T00255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| 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 | 2018-07-02 |
| Returned To Mfg | 2018-07-03 |
| Model Number | T401161 |
| Catalog Number | N/A |
| Lot Number | T00255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-07-02 |