FDA Adverse Event
Injury
Summary report: N
DISPOSABLE PURSTRING 65 INSTRUMENT
MDR report key: 2221281
·
Received August 17, 2011
Report
- Report Number
- 2647580-2011-00548
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 29, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDJ
- PMA / PMN Number
- K901107
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: A STRING WAS STUCK IN THE DEVICE, SO IT COULD NOT BE REMOVED. THE SURGEON HAD TO RESECT MORE TISSUE THAN WHAT WAS ORIGINALLY PLANNED DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PATIENT CAVITY. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE PURSTRING 65 INSTRUMENT | DISPOSABLE SURGICAL STAPLING DEVICE | GDJ | USSC PUERTO RICO | P1C0684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |