FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO CLIP 5MM
MDR report key: 140229
·
Received December 22, 1997
Report
- Report Number
- 1219161-1997-01938
- Event Type
- Malfunction
- Date Received
- December 22, 1997
- Date of Event
- November 25, 1997
- Report Date
- November 25, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
1/9/1998-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. QA IS UNABLE TO RELIABLY DETERMINE THE CAUSE OF THE DIFFICULTY EXPERIENCED AS THE INSTRUMENT WAS RETURNED WAS RETURNED FULLY FIRED.
Description of Event or Problem · 1
THE PRODUCT WAS USED DURING A LAP CHOLE PROCEDURE. REPORTEDLY, THE CLIPS WOULD NOT LOAD PROPERLY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE ENDO CLIP 5MM | DISPOSABLE CLIP APPLIER | GCJ | UNITED STATES SURGICAL CORPORATION | NA | U7K07M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |