FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE VISIPORT 5MM-11MM
MDR report key: 90646
·
Received May 7, 1997
Report
- Report Number
- 2647580-1997-00457
- Event Type
- Malfunction
- Date Received
- May 7, 1997
- Report Date
- April 10, 1997
- Manufacturer
- UNITED STATED SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
6/23/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT LEAKED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE VISIPORT 5MM-11MM | DISPOSABLE SURGICAL TROCAR | GCJ | UNITED STATED SURGICAL CORP. | NA | P6F271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |