FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS
MDR report key: 232328
·
Received April 29, 1999
Report
- Report Number
- 1527736-1999-02555
- Event Type
- Malfunction
- Date Received
- April 29, 1999
- Date of Event
- April 7, 1999
- Report Date
- April 7, 1999
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A VIDEO ASSISTED THORACIC SURGERY. IT WAS REPORTED BY THE AFFILIATE THAT THE 1ST TSB45 INSTRUMENT ANVIL DISLODGED AFTER FIRING AND THE STAPLES MALFORMED. A 2ND DEVICE WAS USED AND AFTER FIRING THE ANVIL DISLODGED SO THE JAW WOULD NOT OPEN NOR CLOSE AND AGAIN THE STAPLES MALFORMED AND CUTTING AND WAS INCOMPLETE. THE SURGEON PUT SOME OVERSTITCHES TO CLOSE THE TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS | LINEAR CUTTERS- ENDOSCOPIC | KOG | ETHICON ENDO-SURGERY | NA | M4DH2H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |