FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PURSTRING 45
MDR report key: 122424
·
Received September 23, 1997
Report
- Report Number
- 2647580-1997-01154
- Event Type
- Malfunction
- Date Received
- September 23, 1997
- Date of Event
- August 26, 1997
- Report Date
- August 28, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A TOTAL GASTRECTOMY PROCEDURE. REPORTEDLY, THE SUTURE DISENGAGEED. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PURSTRING 45 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORPORATION | NA | P7B94 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |