FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO UNIVERSAL 65-4.8
MDR report key: 124306
·
Received September 29, 1997
Report
- Report Number
- 1219161-1997-01348
- Event Type
- Malfunction
- Date Received
- September 29, 1997
- Date of Event
- September 2, 1997
- Report Date
- September 5, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
11/05/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE PRODUCT WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE. THE SURGEON USED ANOTHER INSTRUMENT 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 ENDO UNIVERSAL 65-4.8 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |