FDA Adverse Event
Malfunction
Summary report: N
HERCULES III 360
MDR report key: 3901795
·
Received May 8, 2014
Report
- Report Number
- 1124841-2014-00061
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 21, 2014
- Report Date
- April 22, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- MWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL 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 MORE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING STERILE PROCESSING (AFTER AN OPCAB PROCEDURE) THE SLEEVE PINS FELL OFF THE HERCULES 360. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING ANOTHER CLINICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280149 | HERCULES III 360 | UNIVERSAL STABILIZER ARM | MWS | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 001-401-160 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |