FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE PREMIUM MULTIFIRE TA 30-3.5
MDR report key: 81141
·
Received April 1, 1997
Report
- Report Number
- 1219930-1997-00752
- Event Type
- Malfunction
- Date Received
- April 1, 1997
- Date of Event
- February 28, 1997
- Report Date
- March 3, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE SUBJECT DEVICE REVEALED THAT THE DISTAL END OF THE "#2 LATCHING ROD" LIFTED AND BECAME DISENGAGED FROM THE SUPPORT BLOCK. INTERMITTENTLY, DURING APPROX. OF THE INSTRUMENT, THE LATCH CAM ADVANCED TEH ROD SLIGHTLY FORWARD WHICH RESULTED IN BINDING OF THE ROD BETWEEN THE CAM BRIDGE AND THE SUPPORT BLOCK. THIS INTERMITTENT BINDING PREVENTED THE INSTRUMENT FROM OPENING UPON ACTIVATION OF THE APPROX. BUTTON. AS CORRECTIVE ACTION, PROCESS MODIFICATIONS WERE IMPLEMENTED TO MECHANICALLY PREVENT THE ROD FROM LIFTING AND ELIMINATE FURTHER OCCURRENCE OF THIS CONDITION.
Description of Event or Problem · 1
DURING A LUNG RESECTION PROCEDURE, THE INSTRUMENT JAMMED. HOSP REPORTED THAT NO PT INJURY HAD OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE PREMIUM MULTIFIRE TA 30-3.5 | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | N6G69 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |