FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PREMIUM MULTIFIRE TA 30-4.8
MDR report key: 132910
·
Received November 11, 1997
Report
- Report Number
- 1219930-1997-02457
- Event Type
- Malfunction
- Date Received
- November 11, 1997
- Date of Event
- October 8, 1997
- Report Date
- October 16, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
12/23/97-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT MISFIRED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOS HAS REPORTED NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM MULTIFIRE TA 30-4.8 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORPORATION | NA | N7C21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |