FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE VERSAPORT 5MM-12MM
MDR report key: 128066
·
Received October 20, 1997
Report
- Report Number
- 1219930-1997-02294
- Event Type
- Malfunction
- Date Received
- October 20, 1997
- Date of Event
- September 16, 1997
- Report Date
- September 22, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
11/05/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAVH PROCEDURE. REPORTEDLY, THE INSTRUMENT LEAKS PNEUMOPERITONEUM. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE VERSAPORT 5MM-12MM | DISPOSABLE SURGICAL TROCAR | GCJ | UNITED STATES SURGICAL CORP. | NA | N5D200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |