FDA Adverse Event
Malfunction
Summary report: N
PILLING CORONARY ARTERY SCISSORS, 120 DEGREE, 7"
MDR report key: 1932083
·
Received November 29, 2010
Report
- Report Number
- 1044475-2010-00164
- Event Type
- Malfunction
- Date Received
- November 29, 2010
- Report Date
- November 8, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- LRW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE TWO TIPS OF THE INSTRUMENT ARE BROKEN. THE DEFECT WAS DISCOVERED DURING CLEANING/REPROCESSING DURING THE INSPECTION OF THE DEVICE. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLING CORONARY ARTERY SCISSORS, 120 DEGREE, 7" | CORONARY ARTERY SCISSORS | LRW | TELEFLEX MEDICAL | NA | MM10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |