FDA Adverse Event
Malfunction
Summary report: N
ELITE PASS DISPOSABLE
MDR report key: 1705166
·
Received June 1, 2010
Report
- Report Number
- 1219602-2010-00159
- Event Type
- Malfunction
- Date Received
- June 1, 2010
- Date of Event
- July 24, 2009
- Report Date
- May 7, 2010
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): NO PRODUCT IS BEING RETURNED FOR EVALUATION.(B) (4)
Description of Event or Problem · 1
A PIECE OF THE NEEDLE BROKE OFF AND THE SURGEON COULD NOT LOCATE IT. CONTACT WAS ABLE TO CONFIRM THAT THE PATIENT HAS NOT COMPLAINED OF ANY PAIN OR DISCOMFORT. THERE ARE CURRENTLY NO PLANS FOR ADDITIONAL SURGERY TO ATTEMPT TO LOCATE AND REMOVE THE PIECE. IT IS UNCERTAIN IF X-RAY WAS TAKEN AT THE TIME OF THE EVENT BUT STATED IT WAS NOT LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PASS DISPOSABLE | SUTURE NEEDLE SHUTTLE | NBH | SMITH & NEPHEW ENDOSCOPY | 7210693 | 50226190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |