FDA Adverse Event
Injury
Summary report: N
AUT SUTURE DIV./US SURG. CORP.
MDR report key: 19229
·
Received July 29, 1994
Report
- Report Number
- 19229
- Event Type
- Injury
- Date Received
- July 29, 1994
- Date of Event
- May 18, 1994
- Report Date
- May 19, 1994
- Manufacturer
- U.S. SURGICAL CORP.
- Product Code
- GAG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN PUT MULTIFIRE GIA ON LUNG TISSUE TO RESECT A BLEW FROM RIGHT UPPER LOBE. WOULD NOT DETATCH FROM LUNG TISSUE. WHEN INSTRUMENT BECAME STUCK, PHYSICIAN HAD TO OPEN PT. CHEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUT SUTURE DIV./US SURG. CORP. | MALTIFIRE GIA STAPLER | GAG | U.S. SURGICAL CORP. | GIA MULTIFIRE | 62 MIOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 * | Required Intervention |