FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE MULTIFIRE ENDO GIA 30/45/60
MDR report key: 125058
·
Received October 2, 1997
Report
- Report Number
- 1219161-1997-01369
- Event Type
- Malfunction
- Date Received
- October 2, 1997
- Date of Event
- September 9, 1997
- Report Date
- September 9, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 PRODUCT WAS USED DURING A COLON RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO CLOSE. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE MULTIFIRE ENDO GIA 30/45/60 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |