FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE DPI 30 M DISPOSABLE LOADING UNIT
MDR report key: 166512
·
Received August 5, 1999
Report
- Report Number
- 1219930-1998-00530
- Event Type
- Malfunction
- Date Received
- August 5, 1999
- Date of Event
- April 1, 1998
- Report Date
- April 6, 1998
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
08/06/1999-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE NOT RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A PAN PROTOCOLECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON MANUALLY SUTURED 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 DPI 30 M DISPOSABLE LOADING UNIT | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | N7J69 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |