FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PREMIUM PLUS CEEA 31MM
MDR report key: 133687
·
Received November 18, 1997
Report
- Report Number
- 1219930-1997-02511
- Event Type
- Malfunction
- Date Received
- November 18, 1997
- Date of Event
- October 9, 1997
- Report Date
- October 22, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
12/15/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM PLUS CEEA 31MM | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | N6J139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |