FDA Adverse Event
Injury
Summary report: N
AUTO SUTURE ROTICULATOR 55-4.8
MDR report key: 147324
·
Received February 3, 1998
Report
- Report Number
- 2647580-1998-00104
- Event Type
- Injury
- Date Received
- February 3, 1998
- Date of Event
- January 6, 1998
- Report Date
- January 6, 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
1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO OPEN. THE SURGEON APPLIED ANOTHER DEVICE AND RESECTED THE TISSUE. THE HOSPITAL HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE ROTICULATOR 55-4.8 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP | NA | P7H181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |