FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PREMIUM SURGICLIP M-9.75
MDR report key: 173759
·
Received June 19, 1998
Report
- Report Number
- 2647580-1998-00812
- Event Type
- Malfunction
- Date Received
- June 19, 1998
- Date of Event
- March 24, 1998
- Report Date
- March 26, 1998
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING AN AXILLARY CURAGE PROCEDURE. REPORTEDLY, THE CLIPS SCISSORED. THE SURGEON APPLIED ANOTHER DEVICE 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 PREMIUM SURGICLIP M-9.75 | DISPOSABLE CLIP APPLIER | GAG | UNITED STATES SURGICAL CORP. | NA | P7L61 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |