FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PREMIUM SURGICLIP S-9.0
MDR report key: 91650
·
Received May 14, 1997
Report
- Report Number
- 1219161-1997-00527
- Event Type
- Malfunction
- Date Received
- May 14, 1997
- Report Date
- April 16, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
6/23/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
DURING A CABG PROCEDURE, THE JAWS DID NOT OPEN PROPERLY. THE SURGEON APPLIED ANOTHER DEVICE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM SURGICLIP S-9.0 | DISPOSABLE CLIP APPLIER | GDO | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |