MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-10 for HERC III 360 001-401-160 N/A manufactured by Terumo Cardiovascular Systems Corp..
[69755941]
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
[69755942]
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arm is not stable. End of the arm to which the stabilizer is fixed is not stable and no longer holds the stabilizer. It is unknown if there was a delay in the procedure, if there was blood loss and 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
[74621987]
The returned sample was visually inspected, during which it was discovered that the expiration date had passed prior to the event date of this complaint. Upon evaluation of the sample, it was confirmed that the collet of the arm would not tighten around a ball attachment of an atlas or titan as it should when the cable wasn't tightened. Once the cable was tightened, as it would be during use, the attachment was completely stable within the arm. As the hercules arm is a reusable device, and the arm allows disposable attachments and stabilizers to be installed and removed to the collet, it is likely that damage occurred to the collet, pushing the prongs out and over time, moving the prongs outward so that they no longer had a tight fit around the ball attachments. 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 | 1124841-2017-00038 |
| MDR Report Key | 6397039 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-10 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-03-10 |
| 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 | 2017-03-10 |
| Model Number | 001-401-160 |
| Catalog Number | N/A |
| Lot Number | 70680 |
| 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 | 2017-03-10 |
| Returned To Mfg | 2017-03-28 |
| Model Number | 001-401-160 |
| Catalog Number | N/A |
| Lot Number | 70680 |
| Device Expiration Date | 2016-03-31 |
| Device Availability | R |
| 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 | 2017-03-10 |