FDA Adverse Event
Malfunction
Summary report: N
IRIS SCS 4-1/2 CVD TC
MDR report key: 3181629
·
Received June 14, 2013
Report
- Report Number
- 2523190-2013-00031
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 30, 2013
- Report Date
- June 13, 2013
- Manufacturer
- INTEGRA CORK, PA INC
- Product Code
- LRW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTED TIP BROKE WHILE DR USING TO CUT TISSUE IN CYST REMOVAL. DOCTOR WAS ABLE TO RETRIEVE BROKEN PIECE. CUSTOMER REPORTS (ON (B)(6) 2013) TIP OF SCISSOR BROKE IN WOUND WHILE EXCISING A CYST ON PTS BACK. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271779 | IRIS SCS 4-1/2 CVD TC | M5-GENERAL SURGERY | LRW | INTEGRA CORK, PA INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |