FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE MULTFIRE ENDO GIA 30-3.5
MDR report key: 38896
·
Received September 16, 1996
Report
- Report Number
- 2647580-1996-00082
- Event Type
- Injury
- Date Received
- September 16, 1996
- Date of Event
- August 9, 1996
- Report Date
- August 19, 1996
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
10/4/96-SUPPLEMENTAL REPORT SUBMITTED WITH ADD'L INFO ENTERED IN SECTIONS D-7, D-8 AND D-9. EVALUATION INDICATED AND CODES ENTERED IN H-3 AND H-6.
Description of Event or Problem · 1
THE DEVICE WAS APPLIED DURING A PNEUMOTHORAX PROCEDURE. REPORTEDLY, THE STAPLE LINE WAS INCOMPLETE. THE SURGEON RESECTED THE TISSUE AND COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE HOSP HAS REPORTED THAT THE PT'S STATUS IS SATISFACTORY. DATE DEVICE EXPIRES: 5/31/2001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE MULTFIRE ENDO GIA 30-3.5 | DISPOSABLE LOADING UNIT | GCJ | UNITED STATES SURGICAL CORP. | NA | P6D162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other |