FDA Adverse Event
Malfunction
Summary report: N
FIRSTPASS SUTURE PASSER
MDR report key: 2331823
·
Received October 21, 2011
Report
- Report Number
- 2032380-2011-00125
- Event Type
- Malfunction
- Date Received
- October 21, 2011
- Date of Event
- January 1, 2011
- Report Date
- October 3, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- HWQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PT'S AGE AND GENDER HAVE BEEN REQUESTED BUT NOT RECEIVED. REFERENCE MFR'S REPORT # 2032380-2011-00126, 2032380-2011-00127, 2032380-2011-00128.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGERY USING THE FIRSTPASS SUTURE PASSER THE INSTRUMENT WOULD NOT PROPERLY LOAD THE FIRSTPASS NEEDLE AND SUTURE CAPTURE. THE PHYSICIAN ATTEMPTED TO LOAD THREE DIFFERENT FIRSTPASS NEEDLE AND SUTURE CAPTURES DURING THE PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIRSTPASS SUTURE PASSER | SUTURE, PASSER | HWQ | ARTHROCARE CORP. | 7379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |