FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE PREMIUM MULTIFIRE TA 90-3.5
MDR report key: 162005
·
Received April 9, 1998
Report
- Report Number
- 1219161-1998-00669
- Event Type
- Injury
- Date Received
- April 9, 1998
- Date of Event
- March 12, 1998
- Report Date
- March 12, 1998
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
4/01/1999-SUPPLEMENTAL REPORT SENT TO FDA. ADDITIONAL INFO ENTERED IN D-9 (PRODUCT RETURN DATE). DEVICE EVAL INDICATED IN H-3 AND EVAL CODES ENTERED IN H-6.
Description of Event or Problem · 1
THE PRODUCT WAS USED DURING A GASTRECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON RESECTED THE INCOMPLETE STAPLE LINE AND MANUALLY SUTURED TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM MULTIFIRE TA 90-3.5 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |