FDA Adverse Event
Malfunction
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 2201298
·
Received August 3, 2011
Report
- Report Number
- 1124841-2011-00340
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- GCJ
- PMA / PMN Number
- K083194
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO RECEIVED THE ACTUAL DEVICE; UPON EVAL, IT WAS CONFIRMED THAT THE INTERNAL LENS WAS BROKEN, RESULTING IN A BLURRY VISUAL FIELD. VISUAL INSPECTION NOTED MINOR SCRATCHES ON THE ROD AND EYEPIECE OF THE ENDOSCOPE. THIS TYPE OF DAMAGE IS OFTEN ATTRIBUTED TO HANDLING ISSUES. THE DEVICE IFU STATES THAT THE ENDOSCOPE MUST BE HANDLED WITH EXTREME CARE TO PREVENT DAMAGE TO THE DEVICE. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND F/U.
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING ENDOSCOPIC VEIN HARVESTING, THE ENDOSCOPE WAS BLURRY. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM | ENDOSCOPE | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | MCENDO550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |