FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE POWERED MULTIFIRE ENDO GIA 60-4.8
MDR report key: 132578
·
Received November 12, 1997
Report
- Report Number
- 1219930-1997-02474
- Event Type
- Injury
- Date Received
- November 12, 1997
- Date of Event
- October 17, 1997
- Report Date
- October 17, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
122297-SUPPLEMENTAL REPORT #1 SENT TO FDA. THE INSTRUMENT WAS RETURNED DAMAGED, HOWEVER, CO COULD NOT RELIABLY DETERMINE WHETHER THIS DAMAGE OCCURRED DURING USE OR DURING RETURN SHIPMENT OF THE DEVICE. THE INSTRUMENT WAS RESET AND TESTED SATISFACTORILY.
Description of Event or Problem · 1
THE BROKEN CATHETER HAS NOT BEEN REMOVED FROM THE PT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE POWERED MULTIFIRE ENDO GIA 60-4.8 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORP. | NA | N7D146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |